Preservation of Ovarian Function After Hematopoietic Cell Transplant
Condition: Multiple Myeloma; Non-Hodgkin Lymphoma; Hodgkin Disease; Acute Myeloid Leukemia; Myeloproliferative Disorders
MeSH terms: Multiple Myeloma; Hodgkin Disease; Myeloproliferative Disorders
Intervention: Leuprolide; hematopoietic cell transplant; reduced intensity allogeneic HCT
Intervention description: 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; Conventional bone marrow transplant regimen.; 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.
Intervention MeSH terms: Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Post-menarchal

Summary:

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

Eligibility criteria:

        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 will exclude patients if lab results are
                  not available to demonstrate adequate ovarian function prior to initiation of
                  GnRH therapy.