Preservation of Ovarian Function After Hematopoietic Cell Transplant

• Comparison of Number of Participants Who Stopped Menstrual Bleeding [ Time Frame: From Baseline Through Day 365 ] [ Designated as safety issue: No ]
  Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant
• Comparison of Follicle Stimulating Hormone (FSH) Levels [ Time Frame: Baseline, Day 100, Day 180 and Day 365 ] [ Designated as safety issue: No ]
  Comparison of treatment arms; interventional versus observational average FSH levels.
• Comparison of Number of Participants Who Resumed Menstrual Cycles [ Time Frame: Day 365 Post Transplant ] [ Designated as safety issue: No ]
  Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant
• Comparison of Leuprolide Hormone (LH) Levels [ Time Frame: Baseline, Day 100, Day 180 and Day 365 ] [ Designated as safety issue: No ]
  Comparison of treatment arms; interventional versus observational average LH levels during study.
• Comparison of Antimullerian Hormone (AMH) Levels After Transplant [ Time Frame: Day Before Transplant and Day 810 ] [ Designated as safety issue: No ]
  Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.

• Comparison of Number of Participants Who Stopped Menstrual Bleeding [ Time Frame: From Baseline Through Day 365 ] [ Designated as safety issue: No ]
  Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant
• Comparison of Follicle Stimulating Hormone (FSH) Levels [ Time Frame: Baseline, Day 100, Day 180 and Day 365 ] [ Designated as safety issue: No ]
  Comparison of treatment arms; interventional versus observational average FSH levels.
• Comparison of Antimullerian Hormone (AMH) Levels After Transplant [ Time Frame: Baseline, Day 180 ] [ Designated as safety issue: No ]
  Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
• Comparison of Number of Participants Who Resumed Menstrual Cycles [ Time Frame: Day 365 Post Transplant ] [ Designated as safety issue: No ]
  Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant
• Comparison of Leuprolide Hormone (LH) Levels [ Time Frame: Baseline, Day 100, Day 180 and Day 365 ] [ Designated as safety issue: No ]
  Comparison of treatment arms; interventional versus observational average LH levels during study.

Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.

• Drug: Leuprolide
  Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
  Other Names:

  • Lupron Depot-3(R)
  • Leuprolide acetate
• Biological: Myeloablative allogeneic or autologous hematopoietic cell transplant
  Conventional bone marrow transplant regimen.
  Other Name: MAC
• Biological: Reduced intensity conditioning hematopoietic cell transplant
  A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
  Other Name: RIC

• Experimental: Interventional - Received Leuprolide
  Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
  Interventions:

  • Drug: Leuprolide
  • Biological: Myeloablative allogeneic or autologous hematopoietic cell transplant
• Active Comparator: Observational Arm
  Women undergoing RIC (reduced intensity) transplant (HCT) will be observed. Subjects in this arm can use any hormonal method to suppress menses except GnRH agonists.
  Intervention: Biological: Reduced intensity conditioning hematopoietic cell transplant

Inclusion Criteria:

• Interventional Arm:

  • Eligible for myeloablative allogenic or autologous hematopoietic cell transplant (HCT)
  • Post-menarchal female < or = 50 years of age
  • Normal antimullerian hormone (AMH) level and/or follicle stimulating hormone (FSH)/leuprolide (LH) levels for age/stage of puberty
  • Those women who have an FSH > 40 IU/L and whose diagnosis of malignancy and whose chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.

• Observational Arm:

  • Eligible for reduced intensity allogeneic HCT
  • Post-menarchal female ≤ 50 years of age
  • Normal AMH level and/or FSH/LH for age/stage of puberty
  • Those women who an FSH >40 IU/L and whose diagnosis of malignancy and chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.

Exclusion Criteria:

• All Arms:

  • History of ovarian cancer
  • Surgical resection of one or both ovaries. Prior hysterectomy is allowed as long as the ovaries are intact.
  • Use of GnRH agonist in last 12 months
  • History of radiation to the abdomen or pelvis