[c09aa8]: / clusters / 9knumclustersv2 / clust_2673.txt

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Subjects of childbearing potential should be willing to use methods of contraception for the course of the study through days after the last dose of study medication; acceptable methods of birth control include: abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections); NOTE: females are considered of childbearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (a woman who is >= years of age and has not had menses for greater than year)
DONOR: Donors must not be pregnant; donors of childbearing potential must use an effective method of contraception, including one or more of the following: intrauterine device, hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partners vasectomy, barrier methods (condom, diaphragm, or cervical cap), or abstinence from the day of signing consent through day + of the recipients allo- BMT
All patients of childbearing potential must be willing to consent to using effective contraception, ie, intrauterine device, birth control pills, depo-provera, and condoms while on treatment and for months after their participation in the study ends.
All men and women of childbearing potential must be willing to use effective contraception as determined by the principal investigator (including but not limited to abstinence, hormonal contraceptives [birth control pills, injections, or implants], intrauterine device [IUD], tubal ligation, vasectomy) from the time of enrollment to at least six months following the last dose of drug
Men must agree to use adequate contraception (abstinence, vasectomy) or female partner must use (intrauterine device [IUD], hormonal [birth control, pills, injections, or implants], tubal ligation) prior to study entry and for up to months after the last dose
RECIPIENT: Sexually active individuals capable of becoming pregnant who are unable or unwilling to use effective form(s) of contraception during time enrolled on study and for year post-transplant; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partners vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence; women should not breast feed during the interval from study entry to one year post-transplant; males on the protocol must use an effective form of contraception at study entry, and for one year post-transplant
MATCHED RELATED DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partners vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
HAPLOIDENTICAL RELATED DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partners vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
Sexually active individuals capable of becoming pregnant who are unable or unwilling to use effective form(s) of contraception during time enrolled on study and for year post-transplant; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partners vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence; males on the protocol must use an effective form of contraception at study entry, and for one year post-transplant
MATCHED RELATED DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partners vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
HAPLOIDENTICAL DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partners vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
Adequate contraception for women is defined as hormonal birth control or an intrauterine device (safe hormonal contraceptives include contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). In countries where two highly effective methods of contraception are required this will be an inclusion criterion.
Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partners vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy. A man who is sexually active with a woman of childbearing potential must always use a latex or synthetic condom during the study and for months after discontinuing daratumumab
Women of childbearing potential and men who are sexually active must practice reliable contraceptive measures started at least weeks before study therapy and continued for at least weeks following discontinuation therapy; females of childbearing potential must either completely abstain from heterosexual sexual contact or must use methods of reliable contraception; reliable contraceptive methods include highly effective method (intrauterine device, birth control pills, hormonal patches, injections, vaginal rings, or implants) and at least additional method (condom, diaphragm, or cervical cap) every time they have sex with a male; males who are sexually active must be practicing complete abstinence or agree to a condom during sexual contact with a pregnant female or female of child bearing potential; men must agree to not donate sperm during and after the study
Females of childbearing potential and males must use an effective method of contraception from the time of consent until at least days following discontinuation of protocol therapy; however, female subjects who are post-menopausal (including those with premature menopause due to high-dose chemotherapy) are exempted from this requirement; effective methods of contraception include:\r\n* Any intrauterine device (IUD) with a documented failure rate of less than % per year\r\n* Hormonal (birth control pills, injections, or implants)\r\n* Vasectomized partner who is sterile prior subject enrollment and is sole sexual partner of the subject\r\n* Male subjects: latex condom during sexual contact with female of childbearing potential even if he has undergone a successful vasectomy
Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study/lenalidomide: for at least days before starting lenalidomide; while participating in the study including interruptions in therapy; and for at least days after discontinuation/stopping lenalidomide; the two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal (birth control pills, injections, or implants, tubal ligation, partners vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap); FCBP must be referred to a qualified provider of contraceptive methods if needed
Sexually active subjects (men and women) and all subjects of reproductive potential must agree to use two methods of contraception: one highly effective and one other effective method for at least days prior, throughout the avelumab treatment and for at least days after avelumab treatment; highly effective methods are defined as: intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation and partners vasectomy; other effective methods are defined as: latex condom, diaphragm and cervical cap
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
All patients of childbearing potential must be willing to consent to using effective contraception, i.e., intrauterine device (IUD), birth control pills, Depo-Provera, and condoms while on treatment and for months after their participation in the study ends
Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy
Men must agree to use adequate contraception (abstinence, vasectomy, or female partner use of intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation) prior to study entry and for up to one month after the last vaccination
FCBP must agree to use reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: \r\n* For at least days before starting lenalidomide\r\n* While participating in the study; and \r\n* For at least days after discontinuation from the study; the methods of reliable contraception must include a highly effective method (ie, intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and an additional effective (barrier) method (ie, latex condom, diaphragm, cervical cap); FCBP must be referred to a qualified provider of contraceptive methods if needed
Women of childbearing potential must have a negative pregnancy test at time of screening and baseline visits and agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse ) for at least days before starting study drug; ) while participating in the study; and ) for at least days after discontinuation from the study; the two methods of reliable contraception must include one highly effective method (i.e. intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, partners vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap)
Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of the vaccination period; sexually active males must agree to use barrier contraceptive for the duration of the vaccination period
Female patients of childbearing potential are not eligible unless they commit to complete abstinence or have been on methods of birth control, including highly effective method and additional method at the same time (unless committing to complete abstinence of heterosexual intercourse) at least days ( weeks) prior to study enrollment; sexually active females must also agree to remain on methods of birth control, during treatment (including during dose interruptions), and continuing for at least days after the completion of protocol therapy; examples of methods of contraception are as follows:\r\n* Highly effective methods (must use at least ):\r\n** Intrauterine device (IUD)\r\n** Hormonal (prescription birth control pills, injections, implants)\r\n** Tubal ligation\r\n** Partners vasectomy\r\n* Additional effective methods:\r\n** Male condom\r\n** Diaphragm\r\n** Cervical cap\r\nThe two methods of birth control requirement applies to all sexually active females unless they have undergone a hysterectomy or bilateral oophorectomy
Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of the vaccination period; sexually active males must agree to use barrier contraceptive for the duration of the vaccination period
If a female of childbearing potential (FCBP), patient must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: ) for at least days before starting study drug; ) while participating in the study; and ) for at least days after discontinuation from the study; the two methods of reliable contraception must include one highly effective method (i.e. intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, partners vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap); FCBP must be referred to a qualified provider of contraceptive methods if needed\r\n* A FCBP is defined as a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Men or women of childbearing potential (WOCBP) who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.)
Sexually active women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment
Women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment
Sexually active women of childbearing potential must commit to methods of contraception while enrolled on the trial and continue using contraceptives for at least months post study drug administration; sexually active men must commit to method of contraception while enrolled and for months after; hormonal contraceptives such as birth control pills, patches, implants or injections are not allowed in patients who are hormone receptor (HR) positive (+)
Any of the following:\r\n* Pregnant women\r\n* Nursing women (lactating females must agree not to breast feed while taking lenalidomide)\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.)
Pregnant or lactating; patients of childbearing potential must use an effective method of contraception from the time of study entry to at least one year post-transplant; effective methods include intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partners vasectomy, or barrier methods (condom, diaphragm, or cervical cap); males on the protocol, and their partners of child-bearing potential, must also use an effective form of contraception at study entry and for one year post-transplant; women should not breastfeed during the interval from study entry to one year post-transplant
Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment and for months after the last dose of chemotherapy; sexually active men must agree to use barrier contraceptive for the duration of treatment and for months after the last dose of chemotherapy
Pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, abstinence, etc.)
Any of the following: pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, abstinence, etc)
Negative serum beta-human chorionic gonadotropin (B-HCG) within week of the study imaging with documentation of use of appropriate contraceptive measures (examples include abstinence, intrauterine device (IUD), hormonal methods (oral birth control pills, injections, implants), tubal ligation, and partner's successful vasectomy) after the B-HCG for females of childbearing potential