Preservation of Ovarian Function After Hematopoietic Cell Transplant

Phase 2TerminatedNCT01343368

Masonic Cancer Center, University of Minnesota19 enrolled

Overview

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

This study is to use gonadotropin releasing hormone (GnRH) agonist leuprolide prior myeloablative hematopoietic cell transplantation to prevent ovarian dysfunction in post-menarchal women. The primary objective is to determine the effect of GnRH agonists on the incidence of ovarian failure. The secondary objectives are * to determine how effective GnRH agonists are at suppressing menses during * to determine the incidence and timing of resumption of menstrual cycles after HCT * to determine the incidence and timing of resumption of normal FSH and LH levels after HCT * to determine the incidence of normal AMH levels after HCT * to determine the effect of GnRH agonists on immune reconstitution after HCT * to assess the safety and tolerability of GnRH agonists in the context of HCT A total of 47 patients will be accrued in this study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Multiple Myeloma Non-Hodgkin Lymphoma Hodgkin Disease Acute Myeloid Leukemia Myeloproliferative Disorders

Interventions

LeuprolideDRUG

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

hematopoietic cell transplantBIOLOGICAL

Conventional bone marrow transplant regimen.

reduced intensity allogeneic HCTBIOLOGICAL

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.

Eligibility

Sex: FEMALEMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Comparison of Number of Patients With Ovarian Failure

Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH \>40 IU/L) after transplant.

Time frame: Through Day 180 Post Transplant

Secondary Outcomes

Comparison of Number of Patients Who Stopped Menstrual Bleeding

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

Time frame: From Baseline Through Day 365