[c09aa8]: / clusters / clusters342final / clust_48.txt

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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
Pregnant female patients are not eligible for this study
Post-menarchal females may not participate unless a pregnancy test with a negative result has been obtained
TREATMENT: Pregnant women are excluded from this research; the male partner should use a condom; females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation
Female patients who are pregnant are ineligible
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study; based on the established teratogenic potential of alkylating agents, pregnant women will be excluded from this study; female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study; females of childbearing potential must have a negative pregnancy test to be eligible for this study
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 participants who are pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta (b)-human chorionic gonadotropin (b-hCG) or urine pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Known pregnancy or breast feeding; pregnant women are excluded as the effects of 18F-FLT on the fetus are not known, and there is the potential for teratogenic or abortifacent effects; within 48 hours prior to a PET scan, a pregnancy test will be obtained in all female participants of child bearing potential to confirm non-pregnant status; because there is an unknown, but potential, risk of adverse effects in nursing infants, breastfeeding should be discontinued before the mother receives 18F-FLT
Pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)
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)
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): * Women of childbearing potential:** Must have a negative serum or urine pregnancy test within 72 hours prior to re-registration** Must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, before starting pomalidomide** Must agree to ongoing pregnancy testing** Must agree to not become pregnant or breast feed a child during treatment on this protocol* Men must practice complete abstinence or agree to use a condom during sexual contact with a female of childbearing potential, even if they have had a successful vasectomy* Note: All participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
Female patients who are pregnant are not eligible; pregnancy tests must be obtained in girls who are post menarchal
Female who is able to become pregnant must have a negative pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours of starting pomalidomide; female who is able to become pregnant must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective and one additional effective method at the same time; female who is able to become pregnant must agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with female who is able to become pregnant even if they had vasectomy for the duration of study participation, and 28 days after completion of pomalidomide administration; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure while taking pomalidomide; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
The study drug must not be administered to pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)
Women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)
Patients who are pregnant; pregnancy test is required for female patients of childbearing potential
Women of childbearing potential (FCBP) must have a negative urine pregnancy test within 7 days prior to randomization enrollment; female participants enrolled in the treatment arm are advised to not become pregnant during study participation; all women of childbearing potential must agree to either commit to continued abstinence from heterosexual intercourse or to use a reliable birth control method during heterosexual intercourse (oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera, or bilateral tubal ligation, etc., or another acceptable method as determined by the investigator) during the entire period of the trial (5 years or more), and must not intend to become pregnant during study participation and for 3 months after treatment is discontinued if the participant is enrolled in the treatment arm; female participants, if engaging in heterosexual intercourse, must be willing to comply with an acceptable birth control regimen as determined by the investigator
Female patients of childbearing potential must have a negative serum pregnancy test at the time of enrollment
Patients who are pregnant; a 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)
Pregnancy and breast feeding:* Female patients who are pregnant are ineligible* 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* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
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 patients 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; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
Female patients who are pregnant are excluded; patients should not be pregnant or plan to become pregnant while on treatment; a pregnancy test prior to enrollment is required for female patients of childbearing potential
Female subjects 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 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; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is to be treated with MK-3475 (pembrolizumab)
INCLUSION CRITERIA FOR STRATUM C: Female subjects 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 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; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is to be treated with MK-3475 (pembrolizumab)
Pregnancy or breast-feeding female patients must be surgically sterile, be post-menopausal, or must agree to use effective contraception during the period of therapy and for 90 days following the last dose of RO7009789; all female patients with reproductive potential must have a negative pregnancy test prior to enrollment; women or men of reproductive potential may not participate unless they agree to use an effective contraceptive method; female patients should not become pregnant while participating in this research study or for 90 days following therapy; male patients should not father a child while in this research study or for 90 days following therapy
Female patients who are pregnant are ineligible
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 must have a negative urine or serum pregnancy within 72 hours before 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* Note: women of child-bearing potential must agree to use 2 methods of birth control, or be surgically sterile, or abstain from heterosexual activity beginning with the screening visit and for the duration of study participation, through 120 days beyond last dose of MK-3475 administration; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year* Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Female patients who are pregnant are ineligible
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
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
Women of childbearing potential and male patients should use effective contraception during treatment with MM-398 and for 90 days following the final dose of veliparib and MM-398 for both female and male patients; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Female patients who are pregnant are ineligible
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; women of childbearing potential require a negative pregnancy test prior to starting study drug
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Female partners (of childbearing potential) of male patients must also use a highly effective method of contraception throughout this period
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy, whichever is later
Women of childbearing potential should be advised to avoid becoming pregnant while receiving InO; women should not breast-feed during treatment with InO and for at least 2 months after the final dose* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days of starting protocol therapy* Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for 8 months after the last dose of InO* Men with female partners of childbearing potential should use effective contraception during treatment with InO and for at least 5 months after the last dose of InO* Lactating females are not eligible unless they agree not to breastfeed their infants
Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of BAL101553; women of childbearing potential must agree to use highly-effective contraceptive methods for the duration of study participation and for an additional 90 days after the last dose of study drug; highly-effective contraceptive methods include male or female sterilization (bilateral tubal occlusion or vasectomy); intrauterine device (IUD); combined (estrogen- and progesterone-containing) hormonal contraception (oral, vaginal ring or transdermal patch) with an ethinylestradiol dose of at least 30 ug, plus use of male condoms (preferably with spermicides), female condoms, a female diaphragm or a cervical cap; or total sexual abstinence; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; male patients must agree not to donate sperm from the first dose of study drug until 90 days after the last dose of study drug; male patients, without a vasectomy and with a partner of childbearing potential, must agree to use condoms during the study and for at least 90 days after the last dose of study drug; the patient should be instructed that their female partner should use another form of contraception for the duration of the study and continue this use for at least 90 days after the last dose of study drug
Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
The study drug must not be administered to pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)