Overview

This trial is active, not recruiting.

Conditions multiple myeloma, non-hodgkin lymphoma, hodgkin disease, acute myeloid leukemia, myeloproliferative disorders
Treatments leuprolide, hematopoietic cell transplant, reduced intensity allogeneic hct
Phase phase 2
Sponsor Masonic Cancer Center, University of Minnesota
Collaborator Minnesota Medical Foundation
Start date July 2011
End date October 2014
Trial size 47 participants
Trial identifier NCT01343368, 012M93555, 2010LS053

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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 for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
leuprolide Lupron Depot-3(R)
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 transplant HCT
Conventional bone marrow transplant regimen.
(Active Comparator)
Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
reduced intensity allogeneic hct RIC
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.

Primary Outcomes

Measure
Comparison of Number of Patients with Ovarian Failure
time frame: Day 180 Post Transplant

Secondary Outcomes

Measure
Comparison of Number of Participants Who Stopped Menstrual Bleeding
time frame: From Baseline Through Day 365
Comparison of Follicle Stimulating Hormone (FSH) Levels
time frame: Baseline, Day 100, Day 180, 1 year, and 2 years
Comparison of Number of Participants Who Resumed Menstrual Cycles
time frame: Day 365 Post Transplant
Comparison of Leuprolide Hormone (LH) Levels
time frame: Baseline, Day 100, Day 180, 1 year, and 2 years
Comparison of Antimullerian Hormone (AMH) Levels After Transplant
time frame: Day Before Transplant and Day 180 after transplant

Eligibility Criteria

Female participants at least 50 years old.

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.

Additional Information

Official title A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)
Principal investigator Angela Smith, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota.