Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Female patients, if of childbearing potential, must have a negative serum pregnancy test within 72 hours prior to the date of the first dose of study medication.
Female subjects of childbearing potential must have a negative serum pregnancy within three days prior to registration for protocol therapy
Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through follow-up if of childbearing potential
Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
Women with childbearing potential (WOCBP) who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method; a woman of childbearing potential is defined of one who is biologically capable of becoming pregnant; reliable contraception should be used from trial screening and must be continued throughout the study
Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
Pregnancy and breast feeding:\r\n* Female patients who are pregnant are ineligible\r\n* Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment\r\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Female patients who are pregnant are not eligible; Note: a pregnancy test is required for female patients of childbearing potential prior to study entry
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Post-menarchal females may not participate unless a pregnancy test with a negative result has been obtained
Patients who are pregnant; pregnancy test is required for female patients of childbearing potential
Patients who are pregnant; (a negative pregnancy test is required for female patients of childbearing potential)
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Negative serum pregnancy test within 30 days prior to registration for females of childbearing potential.
Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control
If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception
Negative pregnancy test of females with childbearing potential.
Females of childbearing potential must have a negative serum pregnancy test
Female patients of childbearing potential must have a negative serum or urine pregnancy test
Not pregnant and not nursing: a female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months); female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
For all females of childbearing potential, a negative serum pregnancy test must be obtained within 3 days prior to starting study treatment
Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication
Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide: the first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before lenalidomide is prescribed for cycle 1 (prescriptions must be filled within 7 days)
Female research participants of childbearing age must not be pregnant as confirmed by a serum or urine pregnancy test within 1 week of start of treatment; participants must not be breast-feeding
If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Females of childbearing potential must have a negative pregnancy test. It is not known if the antideacetylase activity of this experimental drug may be harmful to the developing fetus or nursing infant.
Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception
Female subjects of childbearing potential must not be pregnant at screening; females of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy); however, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons
Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug
Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception up until three months after of receiving the last drug treatment
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment
For female subjects of childbearing potential:
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 8 days of initiating protocol therapy
Female patients who are pregnant or currently breastfeeding; female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 8 days of initiating protocol therapy
If female of childbearing potential, must have a negative pregnancy test within 7 days of initiating treatment. Childbearing potential is defined by: those who have not been surgically sterilized and/or have had a menstrual period in the past year.
A negative pregnancy test (for females of childbearing potential)
Patient (of childbearing potential) is not breastfeeding, has a negative serum pregnancy test within 72 hours prior to taking study drug, and agrees to abstain from activities that could result in pregnancy from Screening through 180 days after the last dose of study drug, or is of nonchildbearing potential.
Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
Females of childbearing potential who:
Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
If the participant is of childbearing potential, she must have a documented negative urine pregnancy test at the time of screening and randomization and no plans to become pregnant for the duration of study participation.
Have a negative pregnancy test result at Screening for females of childbearing potential
Women must not be pregnant or breastfeeding; all females of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a blood or urine test to rule out pregnancy within 2 weeks prior to registration
Female subjects of childbearing potential must have a negative serum pregnancy test at screening
Negative pregnancy test for females of childbearing potential
Female subjects of childbearing potential must have a negative pregnancy test at screening
Female subjects of childbearing potential must have a negative serum pregnancy test at screening
Female patients must have a negative serum pregnancy test or be of non-childbearing potential.
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients who have menstruated and are of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration
Female patients who are not of child-bearing potential and fertile females of childbearing potential who agree to use adequate contraceptive measures from 2 weeks prior to the study and until 1 month after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 3 days prior to the start of study treatment
Be of non-childbearing potential:
Or, if of childbearing potential,
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated)
Negative serum pregnancy test within 7 days prior to the administration of the study drugs for female patients of childbearing potential.
Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of first cycle of therapy
Female subjects of childbearing potential must:
Male subjects with a female partner of childbearing potential must:
Have a female partner who is NOT of childbearing potential.
Serum or urine pregnancy test (for females of childbearing potential) negative ?7 days of starting treatment
Female subjects of childbearing potential have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti estrogens, or ovarian suppression.
Pregnancy (negative serum pregnancy test to be obtained within 6 days prior to enrollment for subjects of childbearing potential)
Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication
Female participants of childbearing potential are to have a negative serum pregnancy test
Female patients of childbearing potential must have a negative pregnancy test within 1 week prior to beginning study treatment.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Female patients of childbearing potential must agree to use adequate contraceptive measures until 3 months after the last study drug is taken. Females of childbearing potential must have a negative pregnancy test. It is not known if the antideacetylase activity of this experimental drug may be harmful to the developing fetus or nursing infant.
Pregnant and/or breastfeeding; a negative serum or urine pregnancy test is required at screening for all female patients of childbearing potential
Female patients of childbearing potential must have a negative serum pregnancy test and agree to use at least one form of pregnancy prevention during the study and for at least one month after treatment discontinuation; for the purposes of this study, child- bearing potential is defined as: all female patients that were not in post-menopause for at least one year or are surgically sterile (site-specific criteria applying to Avera only)
Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to taking their first dose of BGB324. Male patients and female patients of reproductive potential must practice highly methods of contraception throughout the study and for ? 3 months after the last dose of BGB324.
Female patients of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to initiating dosing. Male and female subjects with reproductive potential must agree to use acceptable contraceptive methods while on study therapy and for 12 week following their last dose of study medication.
Females of childbearing potential (FCBP) must have a negative serum pregnancy test and agree to use appropriate methods of birth control
Female patients of childbearing potential must have a negative serum pregnancy test at the time of enrollment
Have a negative pregnancy test result at Screening for females of childbearing potential
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes; (females of childbearing potential must have a negative serum pregnancy test within 7 days prior to administration of axitinib)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL prior to starting therapy and prior to beginning another cycle (if applicable)
Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of (cycle 1 day 1 [C1D1]) and have adequate contraception; (a female is considered to be NOT of childbearing potential if she has undergone bilateral oophorectomy or if she has been menopausal without a menstrual period for 12 consecutive months)
Women of childbearing potential must:\r\n* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy\r\n* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed\r\n* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
Negative urine or serum pregnancy test for females of childbearing potential
Negative serum pregnancy test at the time of enrollment for females of childbearing potential
Women of childbearing potential must have:\r\n* A negative serum or urine pregnancy test (sensitivity =< 25 IU human chorionic gonadotropin [HCG]/L) within 72 hours prior to the start of study drug administration\r\n* Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Serum/urine pregnancy test (for females of childbearing potential) that is negative within 72 hours prior to initiation of first dose of treatment (a patient is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active)
Has a negative serum pregnancy test within 7 days of first dose of study treatment (female patients of childbearing potential)
Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication.
Female patients of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of registration.
Female patients of childbearing potential must have a negative pregnancy test, as measured by serum or urine testing
Pregnant or lactating (female participant of childbearing potential must have negative serum or urine pregnancy test required within 7 days prior to start of treatment)
Female subjects of childbearing potential must be nonpregnant, nonlactating, and have a negative pregnancy test result at Screening and Day 1 of Cycles 1-6.
Female patients of childbearing potential must have a negative pregnancy test (urine or serum) within 21 days prior to the start of the study drug treatment and must agree to use adequate birth control if conception is possible during the study and up to 30 days after the completion of adjuvant therapy
Female participants of childbearing potential must have a negative serum pregnancy within 72 hours prior to enrollment
Negative urine or serum pregnancy test for women of childbearing potential\r\n* NOTE: females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
Within 7 days of enrollment and with 24 h of starting lymphodepleting chemotherapy: Negative serum pregnancy test (female subjects of childbearing potential).
For female subjects of childbearing potential, a negative serum pregnancy test.
For female subjects of childbearing potential, a negative urine or serum pregnancy test prior to the start of study therapy.
Negative serum pregnancy test at the time of enrollment for females of childbearing potential
Females of childbearing potential must have a negative pregnancy test within 21 days prior to Study Day 0.
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment.
Female patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment; male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
Female participants of childbearing potential must have negative results for pregnancy test performed:
Female patients of childbearing potential must have negative serum or urine pregnancy test within 72 hours of the first dose of MEK162; patient must not be pregnant or breast-feeding; patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 30 days following cessation of treatment
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test
Female subject of childbearing potential should have a negative pregnancy test within 14 days prior to receiving the first dose of study medication
Female subjects of childbearing age must have a negative serum pregnancy test at study entry
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment
Pregnant females are excluded; female subjects of childbearing potential must indicate to their physician that there is not a possibility of being pregnant at the time of enrollment or have a negative pregnancy test prior to initiation of radiation therapy
Female participants of childbearing potential should have a negative serum pregnancy test within 24 hours prior to receiving first dose of trial medication.
Not a woman of childbearing potential (WOCBP) as defined in protocol OR
Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment
Any woman of childbearing potential, unless she: Agrees to take appropriate precautions to avoid becoming pregnant (with at least 99% certainty) during the study and has a negative serum pregnancy test within 7 days prior to starting treatment.
Female subjects of childbearing potential must have a negative pregnancy test at screening; childbearing potential is defined as: participants who have not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries and/or uterus)
Pregnancy and contraception:\r\n* Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential\r\n* Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test
Serum or urine pregnancy test (for females of childbearing potential) negative at screening and at the baseline visit (before the patient may receive the investigational product)
Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication
Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception
Patients of childbearing potential must have a negative pregnancy test within 7 days prior to treatment start to be eligible
Pregnant females are excluded; females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy
For females of childbearing potential, a negative urine pregnancy test must be documented prior to randomization.
Pregnant or breast feeding; females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
Females of childbearing potential must have a negative urine or serum pregnancy test within 1 week prior to the start of treatment
Females of childbearing potential who:
Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
Females of childbearing potential must have a negative pregnancy test within 30 days prior to randomization. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.
A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 14 days prior to initiating study treatment
DONOR: A serum or urine pregnancy test for females of reproductive potential must be conducted within 7 days prior to initiation of apheresis
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to enrollment. Within the frame of this study, female patients of childbearing potential and male patients with partners of childbearing potential must use an effective method of birth control, as described below, as well as their partners. Patients enrolled in the Dose Finding Portion of the Study:
Females of child bearing potential must have a negative serum pregnancy test with 7 days prior to first dose of treatment; female patients of childbearing potential and all male partners must agree to use double barrier methods of contraception throughout the study period and for at least 30 days following investigational product discontinuation
Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected timeframe of the study, starting from the time of the Screening Visit through 3 months (90 days) after the last OBP-301 administration. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each visit before administration of OPB-301. A female not of childbearing potential is one who has undergone bilateral oophorectomy or who has had no menses for 12 consecutive months.
Negative urine or serum pregnancy test in females. Male and female patients with reproductive potential must use an approved contraceptive method if appropriate
Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice two highly effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of durvalumab monotherapy or for at least 180 days after completion of durvalumab/tremelimumab combination therapy. Female patients of childbearing potential must provide a negative pregnancy test (urine) prior to treatment initiation
Female subjects of childbearing potential must have a negative serum pregnancy test at screening; women of childbearing potential are defined as those who have not been surgically sterilized and have had a menstrual period in the past year
Pregnant or breastfeeding - females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
Negative pregnancy test within 14 days of day 1 cycle 1 for female patients of childbearing potential.
Women of childbearing potential must not be pregnant with a negative urine pregnancy test within 72 hours prior to registration and non-lactating; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; woman status post oophorectomy or hysterectomy are considered non-childbearing potential
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of registration
Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication
Females of childbearing potential must have a negative pregnancy test within 30 days prior to enrollment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.
Female subject of childbearing potential should have a negative serum pregnancy testing at screening visit and within 72 hours prior to the first dose of study medication
Females of childbearing potential must have negative results for pregnancy test performed:
Any woman of childbearing potential, unless she:
Female subject of childbearing potential should have a negative serum pregnancy within 48 hours prior to receiving the first dose of study medication
Not pregnant - females of childbearing potential must have a negative pregnancy test within 7 days of apheresis
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the investigational product
Female patients of childbearing potential, negative urine pregnancy test done =< 7 days prior to study registration
DONOR: Not pregnant - females of childbearing potential must have a negative pregnancy test within 7 days of apheresis
Serum/urine pregnancy test (for females of childbearing potential) that is negative at screening and immediately prior to initiation of treatment (first dose).
Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during the period they are receiving the study drug and for 3 months thereafter; abstinence is an acceptable method of birth control; women of childbearing potential will be given a pregnancy test within 7 days prior to administration of cabozantinib and must have a negative urine or serum pregnancy test
Be of non-childbearing potential:
Or, if of childbearing potential,
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to study entry; pregnancy test must be repeated if performed > 14 days before administration of MGCD516)
Female subjects of childbearing potential should have a negative serum pregnancy =< 7 days prior to registration
Serum pregnancy test (for females of childbearing potential) negative at screening
Pregnant or breast feeding; the agents used in this study include pregnancy category D: known to cause harm to a fetus; females of childbearing potential must have a negative pregnancy test prior to starting therapy
Has negative serum or urine pregnancy test for subjects of childbearing potential within 10 days before first dose.
Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to initiating lenalidomide; the first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before lenalidomide is prescribed for cycle 1 (prescriptions must be filled within 7 days)
A female who is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 48 hours (Period 1) or 72 hours (Period 2), respectively, after the last dose of blinatumomab (Female subjects of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test).
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment
Females with childbearing potential must have had a negative urine or serum pregnancy test =< 7 days before the first dose of deferasirox and must also not be breastfeeding
Female patients of childbearing potential must have a negative pregnancy test < 1 week prior to enrollment.
A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 14 days prior to study registration; Note: If study treatment is not initiated within 7 days after the pregnancy test, the pregnancy test must be repeated
Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Negative urine pregnancy test within 1 week prior to Cycle 1 Day 1 for each woman of childbearing potential
Negative urine pregnancy test within 1 week prior to Cycle 1 Day 1 for each woman of childbearing potential
Female patients of childbearing potential who have a positive blood or urine pregnancy test at screening
Pregnant or breast feeding; females of childbearing potential must have a negative pregnancy test prior to starting therapy
INCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Negative pregnancy test for women of childbearing potential; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
Females of childbearing potential must have a negative pregnancy test and agree to use contraception during on-study protocol treatment.
If a woman is of childbearing potential, a negative serum pregnancy test must be documented
If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study
If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study
Female patient of childbearing potential has a negative serum pregnancy test within 7 days of study enrollment
Pregnant or breast feeding; females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG); the first should be performed within 10 to 14 days and the second within 24 hours prior to the start of the study drug; a prescription for lenalidomide for a female of childbearing potential must not be issued by the prescriber until negative pregnancy tests have been verified by the prescriber
Pregnancy or breast-feeding; female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and 6 months after; all female patients with reproductive potential must have a negative pregnancy test (serum/urine) within 48 hours from starting the conditioning chemotherapy
DONOR: Female subjects must have a negative urine or serum pregnancy test within 10 days prior to taking study medication if of childbearing potential or must be of non-childbearing potential; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the subject to be eligible; non-childbearing potential is defined as:\r\n* >= 45 years of age and has not had menses for > 2 years\r\n* Amenorrheic for > 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation\r\n* Post-hysterectomy, oophorectomy, or tubal ligation
Female subjects must have a negative urine or serum pregnancy test if of childbearing potential or be of non-childbearing potential; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the subject to be eligible; non-childbearing potential is defined as:\r\n* >= 45 years of age and has not had menses for > 2 years\r\n* Amenorrheic for > 2 years without a hysterectomy and oophorectomy and a FSH value in the postmenopausal range upon pretrial (screening) evaluation\r\n* Post-hysterectomy, oophorectomy, or tubal ligation
Pregnant or lactating women; female study participants of reproductive potential must have a negative serum pregnancy test at enrollment
Serum or urine pregnancy test (for females of childbearing potential) negative =< 7 days of registration
ENTRECTINIB EXCLUSION CRITERIA: Females of childbearing potential must have a negative serum pregnancy test during screening and must not be breastfeeding or intending to become pregnant during the study
Females of childbearing potential must have negative serum or urine pregnancy test.
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment
Females with childbearing potential must have a negative serum pregnancy test within 14 days prior to treatment start
Women of childbearing potential must:\r\n* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy\r\n* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed\r\n* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days
Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy.
Have a negative pregnancy test if a female with childbearing potential
Female patients of childbearing potential must have a negative serum pregnancy test confirmed within 7 days prior to enrollment
Female subjects of childbearing potential must not be pregnant at screening; females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy); however, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons
Female participants of childbearing potential have a negative urine or serum pregnancy test and must be willing to use an adequate method of contraception
Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment
Patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to CRS and must be practicing an effective form of contraception during the study period
For females of childbearing potential, a negative serum pregnancy test must be documented within 72 hours of receiving the first dose of vorinostat
DONOR: Pregnant females\r\n* NOTE: a serum or urine pregnancy test for females of reproductive potential must be conducted within 7 days prior to initiation of recipient’s conditioning regimen
Negative pregnancy test (urine or serum) for female patients of childbearing potential
A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 7 days prior to initiating study treatment
Female subject's of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication
Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; if applicable, patients must discontinue breastfeeding prior to the first date of treatment on this study
Has negative serum or urine pregnancy test for subjects of childbearing potential
Females of childbearing potential must have a negative urine pregnancy test at screening and be willing to have additional urine pregnancy tests during the study; females considered not of childbearing potential include those who have been in menopause at least 2 years, or had tubal ligation at least 1 year prior to screening, or who have had total hysterectomy
If female, must not be pregnant (pregnancy testing will be performed locally in all female patients of childbearing potential), must not be nursing and must be one of the following:
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment
Females of childbearing potential must have a negative pregnancy test within 1 week prior to treatment with 131I-MIBG
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the investigational product
Pregnant or lactating women; female subjects of childbearing potential must indicate to their physician that there is not a possibility of being pregnant at the time of enrollment or have a negative pregnancy test prior to the initiation of radiation therapy
Pregnant and/or breastfeeding; patients of childbearing potential must have a negative pregnancy test within 14 days of study entry
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 24 hours prior to the initiation of the study and they must agree to ongoing pregnancy testing and to practice contraception
Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen).
Female patients of childbearing potential must have a negative pregnancy test within 14 days of radiation start
Negative pregnancy test in female patients of childbearing potential
Negative pregnancy test in female patients of childbearing potential
STEP 2: Negative pregnancy test in female patients of childbearing potential
Agreement by females of childbearing potential and sexually active males to use an effective method of contraception while participating in this study; women of childbearing potential must have a negative pregnancy test < 2 weeks prior to registration
Pregnant or lactating - women of childbearing potential should use appropriate precautions to avoid becoming pregnant; females of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study treatment start
Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to entering this study
Pregnant females are excluded; women of childbearing age/menstruating must confirm they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy
Females must have a negative serum pregnancy test 24 hours prior to the start of treatment or be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months)
Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen)
Females of childbearing potential must not be pregnant; this will be confirmed by a negative serum pregnancy test within 14 days prior to starting study treatment
Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment.
Women of childbearing potential must have:\r\n* A negative serum or urine pregnancy test (sensitivity =< 25 IU human chorionic gonadotropin [HCG]/L) within 72 hours prior to the start of study drug administration\r\n* Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to study entry
Women who are pregnant or lactating; all female patients with reproductive potential must have a negative pregnancy test prior to day 1
Participants of childbearing potential must have a negative pregnancy test at screening and enrollment; participants of childbearing potential are defined as premenopausal females capable of becoming pregnant, i.e. females who have had any evidence of menses in the past 12 months with the exception of those who had prior hysterectomy (oophorectomy or surgical sterilization); however, women who have been amenorrheic for >= 12 months are still considered to be of childbearing potential if the amenorrhea is possibly due to any other cause including prior chemotherapy, antiestrogens, or ovarian suppression
Negative serum test to rule out pregnancy within 2 weeks prior to registration in females of childbearing potential (non-childbearing potential defined as premenarchal, greater than one year post-menopausal, or surgically sterilized)
Nursing and pregnant females; female patients of childbearing potential and male patients should practice effective methods of contraception such as double barrier method; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; negative urine pregnancy test (women of childbearing potential)
Females of childbearing potential must have a negative serum ?-Hcg pregnancy test result within 7 days of first study dose. Female patients who are surgically sterilized or who are > 45 years old and have not experienced menses for > 2 years may have ?- Hcg pregnancy test waived.
Pregnancy or breastfeeding; (females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin [beta-hCG] pregnancy test result within 7 days prior to the first dose of brentuximab vedotin; females with false positive results and documented verification that the patient is not pregnant are eligible for participation; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy; females of childbearing potential and males who have partners of childbearing potential must agree to use 2 effective contraceptive methods during the study and for 6 months following the last dose of brentuximab vedotin or 8 months following the last dose of nivolumab, whichever is later)
If female and of childbearing potential, have a negative serum or urine pregnancy test during screening. Agree to use a barrier method of contraception if sexually active (both men and women) from the time of administration of the first treatment and for at least 8 weeks after treatment.
For females of childbearing potential, a negative pregnancy test must be documented prior to randomization
Female patients of childbearing potential must have a negative serum or urine pregnancy test
Females of childbearing potential must have negative serum or urine pregnancy test within 7 days prior to study entry; the effects of lapatinib on the developing human fetus are unknown; however, bevacizumab is known to be teratogenic and detrimental to fetal development and endometrial proliferation, thereby having a negative effect on fertility
If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment
A urine pregnancy test will be performed on each fertile premenopausal female prior to entry into the study; patients with childbearing potential must employ effective contraception during the radiation therapy
Positive pregnancy test in a female patient of childbearing potential defined as not post-menopausal for twelve months or no previous surgical sterilization
Pregnant or breast feeding; the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
Negative pregnancy test of the blood within 7 days of starting treatment in female patient of childbearing potential
Be of non-childbearing potential:
Or, if of childbearing potential:
Females of childbearing potential must have a negative pregnancy test result before enrollment. Males and females of childbearing potential must agree to use a highly effective method of birth control during the study for at least 30 days after enrollment in the study.
Pregnant or breastfeeding; females of childbearing potential must have a negative pregnancy test prior to starting therapy
Female and male subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; effective forms of contraception include abstinence, hormonal contraceptive in conjunction with a barrier method, or a double barrier method; women of non-child-bearing potential may be included if they are either surgically sterile or have been post-menopausal for > 1 year\r\n* Note: Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to receiving therapy; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients should be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential
Pregnancy test (serum or urine): negative for females of childbearing potential: a female is considered to be of child bearing potential unless she has had a tubal ligation or is postmenopausal (without a menstrual period for at least one year)
Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
If subject is a female of childbearing potential (FCBP),† she must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide
Pregnant or breast-feeding. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy.
If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding
A negative pregnancy test (if female of childbearing potential).
Female subjects of childbearing potential must have a negative serum pregnancy test at screening; subjects must agree to use a medically appropriate form of birth control from screening until 6 months after the last dose of study medication
Negative serum or urine pregnancy test (females of childbearing potential only).
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Female subject who is pregnant (as verified by urine test at time of screening) or lactating or of childbearing potential and not using acceptable methods of contraception.
Female subjects of childbearing potential must have a negative urine and/or serum pregnancy test within 5 days prior to randomization (MLT Arm and Control Arm) ;
Pregnancy or breastfeeding, or intention of becoming pregnant during the study. Female subjects must either be of non-reproductive potential or have a negative serum pregnancy test result within 14 days prior to initiation of study treatment
If female: not breastfeeding; agrees to not attempt to become pregnant during the study; is surgically sterile or at least 2-years postmenopausal, or if of childbearing potential, has negative screening serum pregnancy test (if serum pregnancy test results are not available at the time of enrollment, a negative urine pregnancy test is required within 24 hours.); if of childbearing potential (including being < 2 years postmenopausal), is willing to practice sexual abstinence or use an effective dual form of contraception with her partner (eg, 2 barrier methods, barrier method plus hormonal method) during treatment and for ? 28 days after the last dose of any study therapy (IV or oral)
RENAL & BLADDER: Female subjects of childbearing potential must not be pregnant at screening; females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy); however, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons
Female subjects of childbearing potential must not be pregnant at screening; females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy); however, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons
Female subjects of childbearing potential should have a negative serum pregnancy test within 72 hours of starting first dose of study drug.
Pregnant or breastfeeding - The agents used in this study fall under Pregnancy Category D - Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days of study drug administration
DONORS: Not pregnant - females of childbearing potential must have a negative pregnancy test within 7 days of mobilization start
Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
A woman of childbearing potential must have a negative serum or urine pregnancy test at screening within 14 days and again within 72 hours prior to dosing
Female patients of childbearing potential have positive urine or serum pregnancy test no more than 7 days prior to starting study drug.
Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline; male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib
Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment, and
Female patients of childbearing potential must have a negative serum or urine pregnancy test
If female with reproductive potential, must have a negative serum pregnancy test prior to the start of study therapy. Females of reproductive potential, as well as fertile men and their female partners of reproductive potential, must agree to use 2 effective forms of contraception.
Female subjects of childbearing potential and male subjects with female partners of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose. Female subjects of childbearing potential must not be breastfeeding, or planning to breastfeed, and must have a negative pregnancy test ?7 days before first study drug administration. Male subjects must also refrain from donating sperm during their participation in the study.
Female participants of childbearing potential must have a negative serum pregnancy test within the 7 days prior to the first study drug administration.
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test (within 7 days prior to study registration)
A negative serum pregnancy test, if female of reproductive potential
Female patients of childbearing potential must have a negative pregnancy test and agree to use two forms of acceptable contraceptive measures from the time of consent through 120 days after discontinuation of study drug administration.
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 7 days prior to initiating study treatment
Patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Pregnant or breast feeding; all females of childbearing potential must have a blood or urine pregnancy test within 2 weeks prior to enrollment to rule out pregnancy
Females of childbearing potential must have a negative serum pregnancy test at screening
Female patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to the start of the study drug treatment and must agree to use adequate birth control if conception is possible during the study and up to 6 months after discontinuation of study drug treatment
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy
Women of childbearing potential only: negative serum pregnancy test done =< 7 days prior to registration; NOTE: female subjects who are pregnant or nursing are excluded from this study; there is no specific mitigation strategy for vismodegib toxicity; however, male patients should be made aware of it during the consent process; although this effect is expected to be reversible with discontinuation of dosing, long-term effects on male fertility cannot be excluded at this time
Female subjects of childbearing potential must have a negative pregnancy test at screening; females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy); however, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, or ovarian suppression or other reasons
Pregnant or breast feeding; the agents used in this study have the potential to harm a fetus; radiation is a known teratogen; there is insufficient information regarding potential for fetal harm during immunotherapy at this time; biological females of childbearing potential must have a negative pregnancy test within 14 days of registration
Serum pregnancy test for female patients of childbearing potential, =< 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception
Female patients of childbearing potential and sexually-active male patients must agree to use an effective method of contraception while participating in this study; women of childbearing potential must have a negative pregnancy test =< 2 weeks prior to registration
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of study drug)
Female patients of childbearing potential must have negative serum pregnancy test within 14 days of starting protocol therapy
Female patients of childbearing potential must have a negative pregnancy test
If female, patient must not be pregnant or breastfeeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy
Negative pregnancy test for females of childbearing potential
If of childbearing potential must have a negative pregnancy test and use an effective method to avoid pregnancy for the duration of the trial and for at least 6 months after completion of study therapy
Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
A negative pregnancy test in female patients of childbearing potential; women must not be breast-feeding
Females of childbearing potential must also agree to ongoing pregnancy testing
Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception
Or, if of childbearing potential,
Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
Female subjects with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy and on the first day of study drug administration.
Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
Female participants of childbearing potential must have 2 negative urine pregnancy tests (with a sensitivity of at least 25 Milli-international units/Milliliter) within 10 to 14 days and within 24 hours prior to receiving study medication.
Females of childbearing potential that do not have a negative pregnancy test.
Negative Serum pregnancy test for females of childbearing potential
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of study entry
Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment
Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
Female subjects of childbearing potential must not be pregnant at screening.
A negative pregnancy test (for females of childbearing potential).
Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method; reliable contraception should be used from trial screening and must be continued throughout the study; a woman of childbearing potential is defined as one who is biologically capable of becoming pregnant
If female of childbearing potential, serum pregnancy test is negative
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to registration\r\n* Childbearing potential is defined as: participants who have not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus)
Females of childbearing potential who:
Females with childbearing potential: Have had a negative serum pregnancy test ?7 days before the first dose of study drug and also must not be breastfeeding.
Male subjects with a female partner of childbearing potential must:
Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to registration and must implement adequate contraceptive measures during study treatment;
A woman is eligible to participate in the study if she is of Non-childbearing potential, has a negative serum pregnancy test within 7 days of the first dose of study treatment, not lactating, and agrees to use adequate contraception during the study until at least 120 days after the last dose of investigational product
For female patients of childbearing potential, have a negative pregnancy test documented prior to randomization.
Negative serum pregnancy test if female and of childbearing potential
Females of childbearing potential must have a negative serum pregnancy test
Females of childbearing potential have a negative serum pregnancy test (preceding 72 hours of first day of BBI608 treatment).
Females of childbearing potential must have a negative serum or urine pregnancy test prior to patient registration
Negative serum pregnancy test in females of childbearing potential
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the investigational product; a positive pregnancy test will prohibit the subject from receiving the investigational product
Any patients of childbearing potential must have a negative pregnancy test
Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose.
Female patients of childbearing potential must have negative urine pregnancy test no more than 3 days prior to starting study treatment
Pregnancy Status Female patients of childbearing potential, must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test.
Negative pregnancy test for females of childbearing potential
Females of childbearing potential must have a negative serum pregnancy test
Female who has been post-menopausal for more than one (1) year or female of childbearing potential agreeing to use a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner or combined birth control pills]) Female of childbearing potential must have a negative from Screening until 90 days after last dose of INTUVAX and/or until completed sunitinib treatment whichever occurs later.blood pregnancy test at Screening, and if randomized to vaccination a negative blood or urine pregnancy test within one (1) day before each dose of Intuvax) and must not be lactating.
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment
Female participants must have a negative pregnancy test at screening if of childbearing potential or be of non-childbearing potential
Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
Negative pregnancy test for females of childbearing potential
Subject is of childbearing potential and does not have a negative pregnancy test.
For females of childbearing potential, must have a negative pregnancy test
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing; postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
Serum pregnancy test for female patients of childbearing potential, =< 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception
Female patients of childbearing potential are not eligible unless a negative pregnancy text result has been obtained
Within 14 days of enrollment: If female of childbearing potential, urine pregnancy test is negative
A woman of childbearing potential who agrees to use a highly effective contraception (i.e., methods with a failure rate of less than 1 % per year) as detailed in in Appendix VII of this protocol 2 weeks before start of first dose of study treatment, during the treatment period and for at least 4 weeks after the last dose of study treatment. Women of childbearing potential must have a negative pregnancy test (?-HCG test in serum) prior to enrollment.
Or, if of childbearing potential,
Females of childbearing potential must have a negative serum pregnancy test within 14 days of treatment
Patient of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing and effective form of birth control
Female subject of childbearing potential should have a negative pregnancy test or documentation of absence of pregnancy by a gynecologist within 2 weeks of initiating radiation therapy
Pregnant and/or breastfeeding; patients of childbearing potential must have a negative pregnancy test within 14 days of study entry
Females of childbearing potential must have a negative pregnancy test within 30 days prior to randomization. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.
Women must not be pregnant or breast-feeding\r\n* Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program\r\n* All females of childbearing potential must have a blood test within 2 weeks prior to registration to rule out pregnancy \r\n* Pregnancy testing is not required for post-menopausal or surgically sterilized women
For female subjects with reproductive potential: a negative serum pregnancy test
Female patient of childbearing potential has a negative serum or urine pregnancy test within 14 days prior to administration of study therapy
Females of childbearing potential (FCBP) must agree to a pregnancy test at study enrollment and to practice contraception during the study
Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.
Female patients who are pregnant or breastfeeding. Female patients of childbearing potential must have a negative pregnancy test and agree to use adequate contraception for the duration of the trial.
Female subject of childbearing potential should have a negative serum pregnancy within 2 weeks prior to starting radiation therapy or undergoing ablation
Pregnant or breast-feeding patients are excluded; female patients of childbearing potential must have a negative serum or urine pregnancy test at the time of enrollment; in addition, female patients of childbearing potential must have negative pregnancy tests within 10 – 14 days prior to starting pomalidomide (can use enrollment pregnancy test if within the 10-14 day limit) AND again within 24 hours prior to initiation of pomalidomide; this protocol defines the following childbearing potential risk categories as:\r\n* Female child/young adult of childbearing potential as a female who has:\r\n** Achieved menarche and/or breast development, in Tanner stage 2 or greater\r\n** Has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\r\n* Note: amenorrhea following cancer therapy does not rule out childbearing potential
Female participants of childbearing potential must not be pregnant at screening
Pregnant and/or breastfeeding; patients that are of childbearing age must have a negative pregnancy test at screening and agree on using contraception during the duration of the study
Female subject of childbearing potential should have a negative serum pregnancy test
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated)
Females of childbearing potential must have a negative urine or serum pregnancy test within one week prior to start of treatment.
Pregnant as determined by a positive serum pregnancy test within 14 days prior to registration on study (for females of childbearing potential)
Female patients of childbearing age must have negative pregnancy test
Female participants of childbearing potential must have a negative urine or serum pregnancy test and must be willing to use 2 adequate methods of contraception starting with the screening visit through 120 days after the last dose of pembrolizumab
A woman of childbearing potential must have a negative serum pregnancy test at screening within 14 days prior to randomization
Female patients of childbearing potential must have a negative pregnancy test within 14 days of radiation start
Females should be using adequate contraceptive measures should not be breast feeding, and must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-childbearing potential
Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception during the study and for at least 6 months after receiving the final treatment of bevacizumab and/or olaparib
Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during the period they are receiving the study drug and for 3 months thereafter; abstinence is an acceptable method of birth control; women of childbearing potential will be given a pregnancy test within 7 days prior to administration of PD-0325901 and must have a negative urine or serum pregnancy test
Females of childbearing potential must have a negative pregnancy test and agree to ongoing pregnancy testing and to practice contraception; (birth control methods should be determined in consultation with the investigator)
For female participants of childbearing potential, a negative pregnancy test must be documented prior to enrollment.
Females of childbearing potential must have a negative serum or urine pregnancy test at screening
Females of childbearing potential should have a negative pregnancy test
Females of childbearing potential have a negative serum pregnancy test.
Negative urine or serum pregnancy test for females of childbearing potential
If female of childbearing potential, negative pregnancy test
Female subjects of childbearing potential must not be pregnant or breast-feeding; female subjects of childbearing potential must have a negative serum or urine pregnancy test; (pregnancy test must be repeated within 72 hours prior to the start of therapy)
Or, if of childbearing potential,
If patient is of childbearing potential, she must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study
If a female of childbearing potential, had a negative serum pregnancy test within 14 days before enrollment, or within 72 hours before enrollment where required
Females who are breastfeeding or pregnant. For females of childbearing potential, a negative screening pregnancy test must be obtained within 72 hours before the first dose of study drug
Female patients of childbearing potential must have negative serum pregnancy test =< 21 days prior to starting study treatment
Patients with reproductive potential (for example, females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy; female patients of childbearing potential must provide a negative pregnancy test (serum or urine) =< 14 days prior to treatment initiation
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test; the anti-proliferative activity of this experimental drug may be harmful to the developing fetus
Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
For females with reproductive potential: a negative serum pregnancy test
Female patients of childbearing potential must have a negative pregnancy test at screening
Negative serum pregnancy test within 7 days prior to enrollment in female subjects with reproductive potential
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)
Females of childbearing potential must have a negative serum pregnancy test
Females of childbearing potential must have a negative serum pregnancy test.
Pregnant females are excluded; women of childbearing age/menstruating must confirm that they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy
Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test; women of child-bearing potential must have a negative pregnancy test prior to the first dose of bevacizumab; male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following the discontinuation of bevacizumab; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Females of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
If female of childbearing age, negative serum pregnancy test within 7 days prior to the first dose of brentuximab vedotin in this study
Both men and women may be enrolled; premenopausal females must have a negative pregnancy test prior to treatment and lactating females will have to discontinue breast feeding to be eligible
If female of childbearing potential, pregnancy test is negative
Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study.
Patients of childbearing age must have a negative pregnancy test
Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to enrollment
A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if she is of childbearing potential
Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy
Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline; male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib
Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test within 14 days of study registration; pregnancy test must be repeated if performed > 14 days before starting study drug
All necessary baseline studies for determining eligibility must be obtained within 14 days prior to enrollment. Serum pregnancy tests (sensitivity of at least 25 mIU/mL), for females of childbearing potential (WCBP) must be completed. The first test must be performed within 10-14 days, and the second test within 24 hours prior to initiation of lenalidomide.
Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study.
Female subjects of childbearing potential must have a negative pregnancy test and both male and female (of childbearing potential) subjects must agree to use reliable methods of contraception during the study.
Pregnant females are excluded; female subjects of childbearing potential must indicate to their physician that there is not a possibility of being pregnant at the time of enrollment or have a negative pregnancy test prior to initiation of radiation therapy
Negative serum pregnancy test in women of childbearing potential; this is a female who has not been postmenopausal for at least 12 consecutive months or who has not undergone previous surgical sterilization
Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes; women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to everolimus initiation
Females with childbearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy
Negative pregnancy test (if woman of childbearing potential)
For females of childbearing potential, a serum pregnancy test within 2 weeks prior to registration; note: if pelvic irradiation is to be given, the serum pregnancy test must be repeated within 48 hours prior to registration
Female patients of childbearing potential must have negative serum or urine pregnancy test; patient must not be pregnant or breast feeding
Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to randomization and be willing to use an adequate method of contraception (e.g. abstinence, intrauterine device, diaphragm with spermicide, etc.) for the course of the study through 120 days after the last dose of study treatment and up to 180 days after last dose of cisplatin
Female subjects of childbearing potential must not be pregnant at screening.
Female patient who is of childbearing potential must have a negative serum pregnancy test result within 3 weeks prior to starting study drugs.
Female subject of childbearing potential should have a negative serum pregnancy within 28 days prior to receiving the first dose of study medication
Females of childbearing potential must have a negative pregnancy test (by serum beta-HCG) within 7 days prior to the start of treatment.
Patients with reproductive potential (eg, females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy; female patients of childbearing potential must provide a negative pregnancy test (serum or urine) =< 14 days prior to treatment initiation
Pregnant females are excluded; women of childbearing age/menstruating must confirm that they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy
Women must not be pregnant or breast-feeding\r\n* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy
Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is not post-menopausal with a positive serum pregnancy test)
Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment
Pregnant or breast-feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy
Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing; postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; surgical sterilization is considered non-childbearing potential; female patients of reproductive potential must agree to employ an effective method of birth control (hormonal or barrier) throughout the study and for up to 3 months following discontinuation of study drug
Serum/urine pregnancy test (for females of childbearing potential) negative at screening and before the patient will receive the study treatment.
A woman of childbearing potential must have a negative serum or urine pregnancy test within 14 days before commencing treatment. Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously
Pregnant or lactating (female participant of childbearing potential must have negative serum or urine pregnancy test required within 7 days prior to start of treatment); male or female of reproductive potential has agreed to use effective contraception method for duration of study treatment
Females of childbearing potential must undergo pregnancy testing based on the frequency outlined in Pregnancy Prevention Risk Minimization Plan and pregnancy results must be negative.
Negative serum pregnancy test in females of childbearing potential
Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is post-menopausal with a positive serum pregnancy test
Female patients of childbearing potential must have a negative serum or urine pregnancy test, whichever is considered standard by the institution
Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment.
Subjects with reproductive potential must have a negative pregnancy test within 14 days before randomization
Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test
Female subject of childbearing potential must have a negative serum pregnancy 10-14 days prior to registration, and again within 24 hours prior to the first dose of lenalidomide
Female subject of childbearing potential must have a negative serum pregnancy 10-14 days prior to registration, and again within 24 hours prior to the first dose of lenalidomide; females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
If female of childbearing potential, participant presents with a negative blood pregnancy test
Or, if of childbearing potential,
Subjects of reproductive potential must agree to the use of acceptable contraceptive methods for the duration of the time on study and a further 6 months after completion of treatment; women of childbearing potential must have a negative blood or urine pregnancy test within 72 hours of start of treatment
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment
Female patients cannot be of childbearing age, or if they are, must have a negative pregnancy test prior to enrollment and be willing to use contraceptives during treatment and continue for 6 additional months
Female subjects who are of non-reproductive potential (Female subjects of reproductive potential must have a negative serum pregnancy test upon study entry).
Negative urine or serum pregnancy test within 7 days before Day 1 (first dose of study medication) if female subject is of childbearing potential (WOCBP).
Female patient of childbearing potential has a negative pregnancy test within 14 days prior to the start of study drug.
Subjects who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female subjects need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if subject is of childbearing potential. Non?childbearing is defined as ? 1 year postmenopausal or surgically sterilized).
Female subjects of childbearing potential must have a negative serum pregnancy test at screening within 96 hours prior to the first study dose.
Female patients who are not of childbearing potential, and female patients of childbearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum pregnancy test within 72 hours prior to start of treatment.
Female subjects who are not of childbearing potential and fertile female subjects of childbearing potential who agree to use adequate contraceptive measures who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment
Females of childbearing potential must have a negative pregnancy test at screening; patients taking oral contraceptives should use an additional method of contraception
Female patients of childbearing potential must have a negative serum or urine pregnancy test at the time of enrollment
Negative pregnancy test for Females of childbearing potential.
Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
Pregnant or lactating; the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk; all females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy; women of childbearing age must use appropriate contraceptive method
Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered. A female not of childbearing potential is one who has undergone bilateral oophorectomies or who is postmenopausal, defined as >45 years of age and without a menstrual period for 12 consecutive months
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Female patients of childbearing potential must have a negative serum or urine pregnancy test
NON-PROGRESSED DIPG (STRATUM 2): Female patients of childbearing potential must have a negative serum or urine pregnancy test
Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours.
Females of childbearing potential (FCBP) must undergo pregnancy testing based on the frequency outlined in the Pregnancy Prevention Risk Management Plan (PPRMP) and pregnancy results must be negative.
Females of Childbearing Potential (FCBP) must have a negative pregnancy test within 10-14 days and again within 24 hours of starting Cycle 1 and must use an effective double-method contraception for ?28 days prior to, during, and for ?28 days after completion of study therapy.
Pregnant or breast feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
Subjects who desire to get pregnant a female of childbearing potential within the next 1.5 years
Females of childbearing potential must have a negative pregnancy test result within 7 days prior to the first dose of study drug.
If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug. If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breastfeeding.
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen).
Pregnant or lactating (female participant of childbearing potential must have negative serum or urine pregnancy test required within 7 days prior to start of treatment)
Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment.
Or, if of childbearing potential,
If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening
Pregnant or lactating (female participant of childbearing potential must have negative serum or urine pregnancy test required within 7 days prior to start of treatment)
If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding.
Female subjects of childbearing age must have a negative serum pregnancy test at study entry
Female patients of childbearing potential must be non-pregnant, non-lactating, and have a negative pregnancy test result prior to enrollment in the study;
If female and of childbearing potential, documentation of negative pregnancy test (serum or urine) within 7 days prior to first dose
If the subject is a female of childbearing potential, has she had a negative serum pregnancy test within the past 21 days?
Female patients of childbearing potential must have a negative serum or urine pregnancy test result at time of pre-treatment screening.
Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of ipilimumab
Females of childbearing potential must have a negative serum pregnancy test
Females of child-bearing potential must be willing to practice acceptable methods of birth control. Additionally, females of childbearing potential must have a negative serum pregnancy test within 7 days prior to start of study drugs, throughout treatment period and for 4 months after last dose of study drugs.
Female patients of childbearing potential must have a negative serum pregnancy test
Female patient has a negative serum pregnancy test within 72 hours prior to taking study drug if of childbearing potential, and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment, or be of non-childbearing potential.
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test
Female patient of childbearing potential has a negative pregnancy test within 14 days prior to the start of study drug
If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment.
Females (childbearing potential): Have had a negative serum pregnancy test before the first dose of study drug and not be breast-feeding.
Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method
Female participants of childbearing potential must have a negative serum pregnancy test
Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception
If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, then she must practice adequate contraception for 30 days prior to treatment administration, have a negative pregnancy test and continue such precautions for 2 months after completion of the treatment administration series.
If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following SBRT
Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy.
Female subject of childbearing potential must have a negative pregnancy test at screening
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes (women of childbearing potential [WOCBP] must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001)
If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate con-traception for 30 days prior to treatment administration, have a negative pregnancy test and continue such pre-cautions for two months after completion of the treatment administration series.
Pregnant or breast feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy.
Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG).
Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method; female patients who are lactating must agree to stop breast-feeding
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative urine pregnancy test within 72 hours or serum pregnancy test within 2 weeks of signing the informed consent document
Or, if of childbearing potential:
Females of childbearing potential must have a negative serum pregnancy test at screening
Pregnant or lactating; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
In addition, women of childbearing potential must consent to use adequate contraception throughout protocol therapy; females of childbearing potential must have a negative urine pregnancy test =< 7 days prior to registration
Females of childbearing potential have a negative pregnancy test within 72 hours prior to initiating study drug dosing
Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
Females of childbearing potential who:
Pregnant women will also be excluded (Phase I, part B and Phase II); all female participants who are pregnant or become pregnant over the course of the study are not eligible to participate; women of childbearing potential will be asked to complete a blood pregnancy test (using 1 teaspoon of blood drawn from a vein by needle stick) at their first study visit, and the test must be negative before the woman can continue in the study; women of childbearing potential will be asked to agree to use appropriate contraceptive measures for the duration of the study; participants with medically verified menopausal status (e.g., via tests of ovarian functioning documented in the participants’ medical record) will not be asked to complete a blood pregnancy test
Female patients of childbearing age must have a negative pregnancy test
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Females of childbearing potential must have a negative pregnancy test result and must agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the last dose of study drug\r\n* Childbearing potential is defined as girls who are > Tanner stage 2, except for those who have documented pan pituitary insufficiency or other hormonal state incompatible with pregnancy\r\n* Urine pregnancy tests are acceptable
For females of childbearing potential, a negative serum pregnancy test must be documented prior to enrollment
If the patient is of childbearing potential, the patient must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study
Serum pregnancy test negative for females of childbearing potential
Female subject of childbearing potential is neither pregnant nor lactating and must have a negative pregnancy test at the screen visit and a negative pregnancy test before dosing. All female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device (IUD), sexual abstinence, vasectomy or vasectomized partner) for the duration of the study
If a woman of childbearing potential, a negative serum pregnancy test prior to randomization.
Female subjects of childbearing potential must have a negative plasma pregnancy test upon study entry
Females of childbearing potential must have a negative pregnancy test; sexually active patients must agree to use contraception prior to, during, and 30 days after last dose
Negative serum pregnancy test at the time of enrollment for females of childbearing potential
Nonpregnant, nonlactating female patients; patients of childbearing potential must implement an effective method of contraception during the study; all women of childbearing potential must have a pre-study negative serum or urine pregnancy test within 7 days prior to study entry
Urine or serum pregnancy test: negative for female patients of childbearing potential
Negative serum pregnancy test for females of childbearing potential
All female patients of childbearing potential including those who are within 1 year of last menstrual period will be required to take a pregnancy test during screening, enrollment and at week 0, 4, 8 and 12
Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen)
Pregnancy; female participants of childbearing potential must have documented negative urine or serum pregnancy test result not older than 7 days; male patients with reproductive potential will be counseled not to procreate during the study
Female subjects of childbearing potential must have a negative serum pregnancy test as per Memorial Sloan-Kettering Cancer Center (MSKCC) guidelines
Pregnant or breast feeding; females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test prior to starting study drug
Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test
Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
Female patients of childbearing potential must have a negative pregnancy test at screening
Female subjects of childbearing potential must have a negative pregnancy test
Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception during the study
Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test prior to enrollment
Pregnant or breast feeding; females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
A negative serum pregnancy test at baseline, but within 21 days of randomization, for persons of childbearing potential only
A female subject is eligible to participate if she is of: Non-childbearing potential or women of childbearing potential must have a negative serum pregnancy test within 72 hours of first dose of study treatment and agree to use effective contraception during the study and for 60 days following the last dose of study treatment.
Females of childbearing potential must have a negative serum pregnancy test
Male and female subjects of childbearing potential must agree to use a highly reliable method of birth control (expected failure rate < 1% per year) from the Screening Visit through 28 days after the last dose of study drug. Women of childbearing potential must have a negative pregnancy test at screening.
A woman of childbearing potential must have a negative serum or urine pregnancy test at screening within 14 days prior to randomization
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled inthe study, if the subject:
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
If of childbearing potential, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year
Individuals not pregnant at enrollment; female subjects of childbearing potential will undergo a pregnancy test prior to imaging
Individuals not pregnant at enrollment; female subjects of childbearing potential will undergo a pregnancy test prior to imaging
Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential at screening
Patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to PET/CT imaging per institution’s standard of care.
Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy; a woman of childbearing potential is defined as one who is biologically capable of becoming pregnant
Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.
Subject is male; or is a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), >= 60 years old, or of childbearing potential for whom a pregnancy test (with the results known prior to investigational product administration) is negative; a negative pregnancy test will be required for all female subjects with child bearing potential; if a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is not capable of becoming pregnant; female must also be non-lactating
Negative serum or urine pregnancy test for female patients of childbearing age and potential (as defined by MSKCC Standards & Guidelines), from assays obtained < 2 weeks prior to study enrollment
ALL PARTICIPANTS: A negative serum or urine pregnancy test for woman of childbearing potential
Negative pregnancy test, to be performed on female patients of childbearing potential within 1 week before administration of radioactive material
Negative serum pregnancy test for female patients of childbearing age and potential (as defined by MSKCC standards & guidelines), from assays obtained < 2 weeks prior to study enrollment; patients will be advised against having unprotected sexual intercourse from the time of the negative serum pregnancy test until after completing their participation in the study
Women must not be pregnant or breast-feeding as the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
Woman of childbearing potential, a negative serum or urine pregnancy test
Woman of childbearing potential, a negative serum or urine pregnancy test
Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative; a negative serum pregnancy test will be required for all female subjects with child bearing potential; if a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is capable of becoming pregnant
Pregnant or breastfeeding (if a female is of childbearing potential, and unsure of pregnancy status, a standard pregnancy test should be done)
Negative serum pregnancy test (female of childbearing potential only)
If of childbearing potential, negative pre-treatment urine or serum pregnancy test
Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment
Or, if of childbearing potential,
Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative; a negative serum pregnancy test will be required for all female subjects with child bearing potential; if a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is capable of becoming pregnant
Female subjects of childbearing potential (unless they have a negative serum or urine pregnancy test within 3 days prior to start of study treatment)
Pregnancy (if a female is of childbearing potential—defined as a premenopausal female capable of becoming pregnant-a pregnancy test should be done)
If of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year
if female of childbearing potential must have a negative pregnancy test within 24 hours of enrollment
All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
If female of childbearing potential, pregnancy test is negative; (in these instances, the patient will need to provide documentation of negative pregnancy test results)
Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to infusion
All females of childbearing age must have a negative pregnancy test before beginning the study
Negative urine pregnancy test within 36 hours prior to study drug administration, if of childbearing potential
Criteria 9, Female subjects of childbearing potential should have a negative serum pregnancy test within 1 week prior to enrollment
Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy 3. A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential 4. Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion 5. Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
Female subject of childbearing potential must have a negative pregnancy test within 72 hours prior to enrollment.
Female patients of childbearing potential must have a negative pregnancy test within 1 week prior to beginning study treatment.
Non-Childbearing Potential: Male subjects and their partners must meet one of the following criteria to be considered of non-childbearing potential:
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to dosing.