Although they will not be considered formal eligibility (exclusion) criteria, physicians should recognize that the following may seriously increase the risk to the patient entering this protocol:\r\n* Psychiatric illness which would prevent the patient from giving informed consent\r\n* Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient\r\n* Patients with a currently active second malignancy other than non-melanoma skin cancers; patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for >=  years; there is an exception for patients with a history of well differentiated thyroid cancer that has progressed to anaplastic thyroid cancer\r\n* Patients who cannot swallow oral formulations of the agent(s)\r\n* Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study ; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)\r\n* Efatutazone is metabolized by cytochrome P, family , subfamily A, polypeptide / (CYPA/), and inhibits CYPC, C, C, and A, and is a substrate of P-glycoprotein (PgP) and breast cancer resistance protein (BCRP)
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Sexually active male or female must be surgically sterile post-menopausal, or must agree to use a physician-approved method of birth control during the study through a minimum of  days after the last study drug administration.
Female patients with negative pregnancy test at Screening and use of acceptable method of birth control for study duration, unless surgically sterile or postmenopausal for at least  year prior to Screening.
Female patients who are not surgically sterile or postmenopausal (for at least  year) must practice at least one of the following methods of birth control throughout the duration of study participation and for at least  months after study treatment:
Non-vasectomized male patients must comply with at least one of the following methods of birth control throughout the duration of study participation and for at least  months after study treatment:
Pregnancy or lactation or unwillingness to use adequate method of birth control.
Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study.
Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any chronic GvHD
Highly effective forms of birth control include:
Highly effective forms of birth control include:
If a female patient, must be surgically sterile, post-menopausal, or must agree to use physician-approved method of birth control during the study and for a minimum of  days after the last study drug administration, or if a male patient with a female partner, must agree to use physician-approved method of birth control during the study and for a minimum of  days after the last study drug administration
Patient on reliable birth control: combined oral contraceptive pill (OCP), long acting reversible contraceptive program (LARCP), bilateral tubal ligation (BLT) and Depo Provera shot/birth control shot
Patient not on reliable birth control
Willingness to use  methods of birth control during the study and for  months after the last dose of ZW
Female subjects must not be pregnant; willing to use  methods of birth control/abstinence if applicable through  days after the last dose of study drug
Patients of reproductive potential must use an acceptable form of birth control or abstain from sexual activity
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for  days after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Female of childbearing potential, unless birth control used on study and  wks post-treatment.
Women of child bearing potential (WOCBP) must be willing to use medically acceptable methods of birth control during the study treatment and for one month after discontinuing study treatment
Subjects who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for  week after last study drug administration
Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, intrauterine device [IUD], ring, condom, sponge, foam)
Male patients must agree to use adequate birth control during the study and up to  days after the last avelumab dose
Patient is a female of childbearing potential (FCBP)* with a negative serum or urine pregnancy test prior to initiation of therapy and agrees to practice appropriate methods of birth control, or the patient is male and agrees to practice appropriate methods of birth control
Subjects of childbearing potential must be willing to practice an approved highly effective method of birth control starting at the time of informed consent and for  year after the completion of the lymphodepletion regimen. Approved methods of birth control are as follows: hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation or hysterectomy; subject/partner status post vasectomy; Implantable or injectable contraceptives; and condoms plus spermicide.
Currently pregnant, nursing, or planning to become pregnant during the study or within  month after study drug administration. Female subjects must be surgically sterile, at least  years menopausal, or using an acceptable method of birth control. If of childbearing potential, the subject must have a documented negative pregnancy test within  hours before surgery.
Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study; if abstinence is not practiced, one of the two methods of birth control should be an oral contraceptive (e.g., oral contraceptive and a spermicide)
Patients who have partners of childbearing potential (e.g. female that has not been surgically sterilized or who are not amenorrheic for >=  months) must be willing to use a method of birth control in addition to adequate barrier protection as determined to be acceptable by the investigator during the study and for  weeks after last study drug administration. Please note that the efficacy of hormonal contraception may be decreased if administered with olaparib.
Women of childbearing potential must have a negative pregnancy test at study entry; all sexually active patients will be educated regarding the teratogenic potential of the chemotherapy they receive, as well as the infectious risks of intercourse; contraceptive methods will be discussed and sexually active patients must agree to use an effective birth control method for the duration of the study; a medically acceptable method of contraception appropriate to the patients underlying disease, risk factors and lifestyle will be offered in consultation with gynecology or adolescent medicine and will commence on study entry; in general, most postmenarchal female patients may qualify to receive depot medroxyprogesterone acetate (DMPA)  mg intramuscularly (IM) or  mg/. mL for subcutaneous (SC) injection; injection needs to be repeated every  months while on study; prior to IM injection, ensure that platelet count is > , x ^/L; patients ineligible or refusing injectable contraceptives will be offered other medically acceptable contraceptives if appropriate, such as oral contraceptives or birth control patch, or barrier methods
Willing to follow strict birth control measures
if male (and whether or not surgically or medically sterile), agree to use during the study and for at least one month after the last dose of study drug a double barrier method of birth control (in addition to any other birth control method practiced by his partner) while engaging in sexual intercourse with a partner who is pregnant, possibly pregnant or able to become pregnant.
Subjects of reproductive potential who do not use effective methods of birth control
Non-pregnant, non-breast-feeding women may be enrolled if they are willing to use  methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as ) surgically sterilized, or ) postmenopausal (a woman who is >=  years of age and has not had menses for greater than  year will be considered postmenopausal), or ) not heterosexually active for the duration of the study; the two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; subjects should start using birth control from study day  throughout the study period up to  days after the last dose of study therapy
All sexually active subjects of reproductive potential are required to use or start using a reliable method of birth control at least  weeks prior to study enrollment, throughout the study, and for at least  months following completion of study therapy.
All participants who are able to have children must practice effective birth control while on study. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.
Women of childbearing potential in agreement to use acceptable birth control methods for the duration of the study and until persistence of the study drug is no longer detected in the peripheral blood; this may be a period of several years; methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception; it is recommended that a combination of two methods be used
Men who could potentially father a child must also use birth control
For women of child bearing potential, documented negative pregnancy test within two weeks of study entry and agreement to acceptable birth control throughout the trial starting with the screening visit through  days after the last dose of study medication\r\n* Abstinence is an acceptable method of birth control
Male subjects with a female partner(s) of child-bearing potential must agree to use acceptable birth control throughout the trial starting with the screening visit through  days after the last dose of study medication
Subjects of reproductive potential must agree to use acceptable birth control methods
Female subjects of childbearing potential must have a negative serum pregnancy test within  days prior to the st dose, if more than  days prior, a urine pregnancy test must be performed before the st dose. The female subject must be willing to use highly effective methods of birth control during the period of therapy and for  months following the last study IP administration. Highly effective methods of birth control include sexual abstinence, hormonal birth control, or intrauterine device (women), vasectomy or a condom with spermicide (men) in combination with barrier methods.
Male subjects who are willing to use highly effective methods of birth control during the period of therapy and for  months following the last IP administration.
All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.
Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more types of birth control during the entire study and for  months after completing the study. Birth control methods may include condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous implants. Another choice is for a subject's sexual partner to use one of these birth control methods. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process.
Using corticosteroids or estrogen-based oral birth control
commit to continued abstinence from heterosexual intercourse (excluding periodic abstinence or the withdrawal method) or begin two acceptable methods of birth control with a Pearl-Index ? %. without interruption from  weeks before starting study drug, throughout study drug therapy and for  months after end of study drug therapy, even if she has amenorrhoea. Apart from abstinence, acceptable methods of birth control are:
Women of childbearing potential and men must agree to use effective methods of birth control for the duration of the study and  months after; methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception; it is recommended that a combination of two methods be used
Subjects of reproductive potential must agree to use acceptable birth control methods
Subjects of reproductive potential must agree to use acceptable birth control methods
Subjects of reproductive potential must agree to use acceptable birth control methods
Subjects of reproductive potential must agree to use acceptable birth control methods
Fertile male subjects must agree to use a medically acceptable contraceptive method (allowed methods of birth control include vasectomy or condom with spermicide) during the trial and for a period of at least  months following the last administration of trial drugs
Women of childbearing potential must have a negative pregnancy test at study entry; all sexually active patients will be educated regarding the teratogenic potential of the chemotherapy they receive, as well as the infectious risks of intercourse; contraceptive methods will be discussed and sexually active patients must agree to use an effective birth control method for the duration of the study; a medically acceptable method of contraception appropriate to the patients underlying disease, risk factors and lifestyle will be offered in consultation with gynecology or adolescent medicine and will commence on study entry; in general, most postmenarchal female patients may qualify to receive depot medroxyprogesterone acetate (DMPA)  mg intramuscularly (IM) or  mg/. mL for subcutaneous (SC) injection; injection needs to be repeated every  months while on study; prior to IM injection, ensure that platelet count is > , x ^/L; patients ineligible or refusing injectable contraceptives will be offered other medically acceptable contraceptives if appropriate, such as oral contraceptives or birth control patch, or barrier methods
Use of an effective means of contraception (men and women) is mandated in subjects of child-bearing potential; female subjects will be advised that they not become pregnant for at least one month after completing participation in the study; avoiding sexual activity is the only certain method to prevent pregnancy; however, if subjects choose to be sexually active, they should use an appropriate double barrier method of birth control (such as female use of a diaphragm, intrauterine device [IUD], or contraceptive sponge, in addition to male use of a condom) or the use of prescribed birth control pills, injections, or implants
Acceptable forms of birth control include condoms, diaphragms, cervical cap, an intra-uterine device (IUD), surgical sterility (tubal ligation or a partner that has undergone a vasectomy), or oral contraceptives, OR the subject must agree to completely abstain from heterosexual intercourse.; abstinence at certain times of the cycle only, such as during the days of ovulation, after ovulation and withdrawal are not acceptable methods of birth control
Premenopausal and using an acceptable form of birth control. Acceptable forms of birth control include: hormonal contraceptives (implantable, oral, patch) used for ?  months prior to screening or double barrier methods (any combination of two of the following: intrauterine device [IUD], male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). All premenopausal females must have a negative urine or serum pregnancy test at screening and on Day  prior to first PRTX- treatment.
Women who are able to become pregnant and men who can father a child must use birth control while on study and for at least  weeks after your last dose of study drug(s); acceptable birth control includes a condom or a diaphragm with spermicidal jelly; and birth control methods that are taken by mouth, injected, or implanted; if you are already using birth control, you must check with the study staff to make sure that it is considered one of the acceptable forms to use in this study
Women of childbearing potential and men who are not practicing an acceptable form of birth control (i.e. diaphragm, cervical cap, condom, surgical sterility or birth control pills. Women whose partner has or men who have undergone a vasectomy must use a second form of birth control).
Pregnant and nursing women should be excluded from the protocol; if the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of  months following the last vaccination therapy; it is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study
Be non-fertile or not pregnant or lactating & agree to use birth control during the study through the end of last treatment visit
Female subjects of child-bearing potential must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use for  days after stopping study medication.
Patients who do not agree to practice appropriate birth control methods while on therapy.
Females must not be pregnant or breast feeding, and must use accepted birth control methods; males must use accepted birth control methods
ELIGIBILITY CRITERIA FOR REGISTRATION: women of child-bearing potential must agree to use an effective method of birth control on trial; an effective method of birth control includes surgical sterilization of woman or her partner, abstinence, or two barrier methods (e.g. condom plus diaphragm); or hormonal methods of birth control (oral contraceptives or intrauterine device)
Male and female patients of reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for the duration of study participation; pregnant and breastfeeding women will not be eligible
Subjects of childbearing potential must agree to utilize effective contraceptive methods of birth control during study participation and for  days following the last treatment with IMP (Investigational Medicinal Product)
Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more types of birth control during the entire study and for  months after completing the study. Birth control methods may include condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous implants. Another choice is for a subject's sexual partner to use one of these birth control methods. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process.
Women must not be able to become pregnant (e.g. post-menopausal for at least  year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.
Subjects are required to agree to practice effective birth control (i.e. abstinence, intrauterine device for female subjects) during the study period.
Sexually abstinent or correct and consistent use of one of the following methods of birth control in addition to a male partner using a condom from Screening to  months after the last dose of study drug:
vasectomy in male partner. Male patients must agree to sexual abstinence or to consistently and correctly use a condom in combination with one of the above methods of birth control from Screening to  months after the last dose of study drug.
All participants who are able to have children must practice effective birth control while on study. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor
Male patients must agree to use adequate birth control during the study and up to  months after discontinuation of study drug treatment
Male and female patients who do not agree to practice approved methods of birth control for the duration of the study are ineligible
Adequate birth control
Must agree to use effective birth control (such as a condom) or abstinence during and for a period of  months after the last vaccination therapy
Female and male subjects must agree to use a medically acceptable method of birth control prior to screening and agree to continue its use throughout the study; females of childbearing potential should be counseled in the appropriate use of birth control while on this study
Patients must be able to rinse and expectorate study medication rather than swallow it; female patients must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential
Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for  month following the last study drug infusion and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of  months) or surgically sterile. 'Maximally effective birth control' means that the patient, if sexually active, should be using a combination of two methods of birth control that are approved and recognized to be effective by Regulatory Agencies
The participant, if male, is sterile or agrees to use a reliable method of birth control.
The participant, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control.
Must use acceptable form of birth control throughout the study. After the final dose of study drug, an acceptable form of birth control must be used for  weeks for women of childbearing potential (WOCBP) and  weeks for men who are sexually active with WOCBP
Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use  methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin  weeks prior to dosing and must continue for  months after the last dose of daratumumab
If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use two methods of birth control or is considered highly unlikely to conceive during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment
Subjects who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protections as determined acceptable by the principal investigator during the study and for  week after the last dose of abiraterone acetate
Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures during the course of the trial and for at least one month after discontinuing study drug.
Males, and female patients who are biologically capable of having children, must agree to use a medically acceptable method of birth control.
Female patients of child bearing potential and non-vasectomized male patients agree to practice appropriate methods of birth control
Female participants must be either surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal, or agree to use a medically effective means of birth control (hormonal or barrier method of birth control; abstinence) prior to study entry and throughout their participation in the treatment phase of this study; female participants of child bearing potential must also have a negative serum pregnancy test within  weeks prior to registration
Agree to use a reliable medically approved method of birth control.
Female subjects and their male partners must agree must agree to use a highly reliable method of birth control
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
Willing to adhere to medically accepted form of birth control to prevent pregnancy (includes: complete abstention from intercourse, condoms, diaphragms, cervical cap, intra-uterine device, history of surgical sterility  tubal ligation or vasectomy in patient or partner, or oral contraceptive)
Male and female subjects of reproductive potential agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) and abstain from other methods of conception during the study and for  months following the study cell infusion or proof of sterility
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
Patients with childbearing potential must agree to use appropriate forms of birth control
Female subject is either post-menopausal or surgically sterilized; females of childbearing potential must have a negative serum pregnancy test within  hours prior to prescribing bendamustine and must commit to continued abstinence from heterosexual intercourse or use TWO acceptable methods of birth control (at least one barrier method) AT THE SAME TIME during the study and for  months after the last study drug; sexually active males must use a medically acceptable form of birth control for the duration of the study and for  months after last dose of drug
Female is not breastfeeding, is postmenopausal or surgically sterile; demonstrates non-pregnant state, and agrees to use  acceptable methods of birth control throughout the trial, until  days after the last dose of treatment
If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device) from the time of consent through  months following the last dose of study drug
Male and female patients of reproductive potential must agree follow accepted birth control measures
Sexually active male subject and his female partner who is of childbearing potential must use  acceptable methods of birth control from Screening through  months after the last dose of study drug. * Two acceptable methods of birth control are as follows:
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for  days after the last dose of study treatment; acceptable methods of birth control include condoms with birth control foam, birth control pills, implantable or injectable birth control, birth control patch, intrauterine device (IUD), or diaphragm with spermicidal gel; male patients must use an effective barrier method of contraception (i.e. , condoms with birth control foam or diaphragm with spermicidal gel) during the study and for  days following the last dose of study treatment if sexually active with a female of childbearing potential; contraception must be in place at least  weeks prior to initiating study treatment; a female of childbearing potential is 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)
Willing to employ adequate and appropriate birth control if applicable\r\n* NOTE: This study is for patients aged  and older and most female patients will have entered menopause by this time; however patients should not become pregnant while on this study; pre-menopausal women need to use birth control while on this study and women should not breastfeed a baby while on this study; any man treated on this study will also need to use contraception if his partner is a premenopausal female; patients should check with their health care provider about what kind of birth control methods to use and how long to use them
Note: Women with potential to have children must be willing to practice acceptable methods of birth control during the study
Participants who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator (PI) during the treatment period and for  week after last dose of AA
Two acceptable forms of birth control include:
All women of childbearing potential and sexually active men must agree to use adequate methods of birth control throughout the study which includes use of oral contraceptives with an additional barrier methods, double barrier methods, Depo-Provera, permanent sterilization of patient or partner or total abstinence
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the treatment period and for  week after last dose of abiraterone acetate
Willingness to use birth control while on study
Females of childbearing potential and males able to father a child must be willing to practice acceptable methods of birth control to prevent pregnancy
Participants who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the treatment period and for  week after last dose of enzalutamide
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for  week after last dose of abiraterone acetate
Willingness to discontinue sex hormonal therapy, e.g. birth control pills, prior to registration and while on study
REGISTRATION INCLUSION CRITERIA: If a woman of childbearing potential, patient must use two forms of effective contraception for a minimum of  months following trastuzumab; effective methods of birth control include use of established oral, injected, or implanted hormonal methods of birth control, intrauterine device (IUD), intrauterine system (IUS), and condoms
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for  week after last dose of abiraterone acetate
Women of childbearing potential are requested to use acceptable methods of birth control for the duration of the study and until persistence of the study drug is no longer detected in the patient. This may be a period of several years. Methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception. It is recommended that a combination of two methods be used. Patients must have normal organ and marrow function as defined below:
Subjects of reproductive potential agree to use birth control throughout their participation in this study, and for three months following study termination.
Patients of childbearing potential (females who have not been postmenopausal for at least  consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) must be willing to practice birth control during the study
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control .
consistent and correct use of  of the following highly effective methods of birth control for one month prior to the start of the study agent and  months after the last dose:
Non-pregnant and non-nursing; women of child bearing potential and men must agree to use an appropriate method of birth control throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier methods (diaphragm plus condom)
Patients of both gender must practice a barrier method of birth control while participating in this trial
Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, IUD, ring, condom, sponge, foam).
Highly effective forms of birth control include:
Females must be post-menopausal for more than  years or surgically sterile or practicing acceptable forms of birth control.
And, if heterosexually active, agree to consistently use  forms of highly effective birth control
Adequate birth control when appropriate
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with ipilimumab or dabrafenib; patients should agree to use an appropriate method of birth control while on study; examples of adequate forms of birth control for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator
Any risk of pregnancy - ALL female patients must have an effective means of birth control or be infertile due to hysterectomy, fallopian tube surgery, or menopause
FCBP must agree to use a highly-effective form of birth control while taking the study drug and for  month after the last dose of study drug; highly-effective forms of birth control include implants, injectables, birth control pills with  hormones, some intrauterine devices (IUDs), or having a sterilized partner; the type of birth control used must be discussed with and approved by the attending physician prior to initiation of study drug
Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least  months after the last dose of study treatment in such a manner that the risk of pregnancy for a partner is minimized.
Female parents of childbearing potential must be willing to use  methods of birth control or be surgically sterile.
The patient, if female and of child bearing potential, must be postmenopausal or surgically sterile, or on one of the following methods of birth control for a minimum of  months prior to entry into this study and throughout the duration of the study: intrauterine device (IUD), oral contraceptives, or Depo-Provera; this criteria can be waved at the discretion of the investigator if the patients intracranial tumor is considered life threatening and the  month wait required is not in the best interest of the patient; in this case, the patient must be on a reliable form of birth control as stated above
Willing to use physician approved birth control method
Effective birth control includes absolute abstinence, or double barrier birth control methods, i.e. condom and one of the following: combined oral contraceptive, diaphragm, depot contraceptive injection.
Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner's vasectomy) while on crenolanib and for  months following the last dose of crenolanib. Hormonal contraception alone is not an acceptable method of birth control for the purpose of this trial.
if heterosexually active must use two forms of birth control
If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device, abstinence or other methods prescribed by a licensed healthcare provider) from the time of consent through  days following the last dose of study drug
Male and female subjects must agree to use a highly reliable method of birth control for the duration of the study.
Surgically or biologically sterile or willing to practice acceptable birth control, as follows:\r\n* Women of childbearing potential must have a negative serum or urine pregnancy test within  days of day  of study treatment; women of childbearing potential must agree to abstain from sexual activity or use a medically approved contraceptive measure/regimen during and for  months after the treatment period; acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence\r\n* Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for  months after the treatment period; acceptable methods of birth control include: barriers (condoms), oral contraceptive, IUD, transdermal/implanted or injected contraceptives, and abstinence
Adequate birth control methods for the duration of the study
If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device) from the time of consent through  months following the last dose of study drug
Women with child-bearing potential must be willing to practice acceptable methods of birth control during the study
Unwillingness to practice birth control
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for  week after the last dose of abiraterone acetate
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for  week after last study drug administration
Female subjects of child-bearing potential who are capable of conception must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include abstinence, intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject ? years of age and of child bearing potential must agree to practice two acceptable methods of birth control during the study period. All reproductive female subjects must have a negative serum pregnancy test during the screening visit.
Male and female patients must agree to use a highly reliable method of birth control.
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for  week after last dose of abiraterone acetate
Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to  weeks after the last dose of study medication.
Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to  weeks after the last dose of study medication.
Current use of hormone-containing forms of birth control such as implants (i.e. Norplants, or injectables ( i.e. depo-provera)
Adequate birth control
Men capable of producing offspring and not surgically sterile must practice abstinence or use a barrier method of birth control.
Women with potential to have children must be willing to practice acceptable methods of birth control during the study;
Use of acceptable birth control
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel; appropriate methods of birth controls for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator; male with partners of child bearing potential must practice reliable method of contraception (condoms) approved by the investigator; the patient must agree to continue use of birth control for at least  months after receiving last dose of study drugs
Female patients of childbearing age not on effective birth control
Patients of reproductive age must agree to use a medically accepted form of birth control while on the study.
Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (IUD, birth control pills, or barrier device) during and for  months after completion of trial therapy.
Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, intrauterine device [IUD]) or currently pregnant
Male and females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, use of an intrauterine device (IUD) or abstinence; () female patients must have a negative pregnancy test at screening; () female patients of childbearing potential must agree to use an acceptable method of birth control (excluding hormonal birth control methods) for  hours prior to admission and to continue its use during the study and for at least  days after the final dose; () male patients must agree to use an acceptable form of birth control from study day  through at least  days after the final dose
Either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control during study treatment and for  months afterwards
For sexually active females, patient agrees to use acceptable method of birth control
If male, must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for  months following the last dose of investigational drug or cytarabine, whichever is later.
Acceptable birth control.
Male and female subjects of child-bearing potential must agree to use medically acceptable methods of birth control throughout the study and for thirty () days after the last dose of study medication.
Men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse if receiving topical treatment during the study, and for  weeks after stopping topical treatment
Agree to utilize medically accepted methods of birth control during study participation and for  days following the last treatment with study drug if a female subject is of childbearing potential or if a male subject has an opposite sex partner of child bearing potential.
Women of childbearing potential (FCBP) must have a negative urine pregnancy test within  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 ( years or more), and must not intend to become pregnant during study participation and for  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
If currently menstruating, subjects must use a reliable method of birth control
Premenopausal women taking non hormonal intra-uterine device (IUD) birth control method will be eligible, if they have been on the same IUD for at least  months prior to enrollment and plan to continue using the same method throughout the study
Female patients of childbearing potential must agree to use an acceptable method of birth control from the signing of informed consent form and to continue its use during the study and for at least  days after the final dose
Male patients must agree to use an acceptable form of birth control from study day  through at least  days after the final dose
Breast surgeons may recommend that this patient population should not take any oral contraceptives or hormone eluting intrauterine devices (IUDs); sexually active heterosexual women must agree to use an effective form of birth control for the duration of study participation; women who are NOT having ) a hysterectomy, ) fallopian tubes removed and/or ) ovaries removed at the time of their breast surgery will also be required to use an effective form of birth control for  days following the last dose of study medication\r\n* The following women are not considered able to bear children and therefore are eligible to participate without the use of concurrent birth control:\r\n** Female with hysterectomy with intact functioning ovaries\r\n** Female with fallopian tubes cut, tied, sealed, or removed\r\n** Female with sterilization implant (e.g. Adiana, Essure) place >  months prior to beginning study drug\r\n* One of the following methods of birth control must be used by sexually active women of childbearing potential for the duration of study participation and for  days following the last dose of study medication:\r\n** Combined oral contraceptive pill in continuous use for >  days prior to study entry\r\n** Vaginal ring (e.g.NuvaRing) in continuous use for >  days prior to study entry\r\n** Skin patch (e.g. Ortho Evra) in continuous use for >  days prior to study entry\r\n** Injection (e.g. Depo-Proveera, Noristerat) in continuous use prior to study entry\r\n** IUD\r\n** Diaphragm, cervical cap, or cervical shield with spermicide\r\n** Contraceptive sponge (e.g. Today Sponge)\r\n** Condom (male or female type) plus spermicide\r\n** Male partner who has had a vasectomy\r\n* Women who indicate that they are abstinent from heterosexual encounters for the duration of study participation and for the  days following the last dose of study medication will not be required to use birth control
If female, agreement to use birth control (any form) to avoid pregnancy during study procedures
WOCBP should be willing to use  methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for  months after the study is concluded; WOCBP are those who have not been surgically sterilized or have not been free from menses for >  year; the two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; the male partner of WOCBP subjects enrolled into the trial should be instructed to use a condom by their female partner enrolled in the trial
If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control
If male, must be surgically sterile or willing to practice two effective methods of birth control
Participants will be required to use a medically-approved method of birth control or abstinence if their sexual partner is of child-bearing potential
CONTROL GROUP
Participants of reproductive potential agree to remain abstinent, or use a medically accepted method of birth control
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrel implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Agree to use an acceptable form of birth control for a period of  days after the Cu--TP injection
Not currently on estrogen medication for birth control, menopause, or other reason
Willingness to use birth control while on study
CONTROL GROUP
Birth weight below five pounds, premature birth prior to  weeks of gestation, or ischemic episode at birth
Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for  weeks after last study drug administration
Willing to use non-hormonal birth control: Male subjects who are surgically sterile (eg, after vasectomy) or who must agree to use an adequate method of contraception during participation in the trial and for at least  complete month after the final dose of trial medication. Female subjects who are surgically sterile (eg, -sided tubal ligation, resection or ovariectomy, hysterectomy) or post-menopausal (defined as at least  years of age and who have a history of no menses for at least  months) or female subjects of childbearing potential with no male partner, or use an adequate method of contraception during participation in the trial and for at least  complete month after the final dose of trial medication. An adequate method of contraception is defined as one of the following acceptable birth control methods:
Female of child bearing potential (FCBP) and non-vasectomized male agree to practice appropriate methods of birth control
Adequate birth control
Male and female participants with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device, birth control pills, or barrier device) during and for  months after discontinuation of study treatment.
Female patients of child bearing potential and non-vasectomized male patients agree to practice appropriate methods of birth control
Males, and female patients who are biologically capable of having children, must agree to use a medically acceptable method of birth control.