Preservation of Ovarian Function After Hematopoietic Cell Transplant

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Masonic Cancer Center, University of Minnesota
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01343368
First received: March 15, 2011
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Non-Hodgkin Lymphoma
Hodgkin Disease
Acute Myeloid Leukemia
Myeloproliferative Disorders
Drug: Leuprolide
Biological: hematopoietic cell transplant
Biological: reduced intensity allogeneic HCT
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Comparison of Number of Patients with Ovarian Failure [ Time Frame: Day 180 Post Transplant ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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, 1 year, and 2 years ] [ 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, 1 year, and 2 years ] [ 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 180 after transplant ] [ Designated as safety issue: No ]
    Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.


Estimated Enrollment: 47
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
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: hematopoietic cell transplant
Conventional bone marrow transplant regimen.
Other Name: HCT
Active Comparator: Observational Arm
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.
Biological: reduced intensity allogeneic HCT
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343368

Contacts
Contact: Angela Smith, M.D. 612-626-2778 smith719@umn.edu

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Angela Smith, M.D.    612-626-2778    smith719@umn.edu   
Principal Investigator: Angela Smith, M.D.         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Minnesota Medical Foundation
Investigators
Principal Investigator: Angela Smith, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01343368     History of Changes
Other Study ID Numbers: 2010LS053, 012M93555
Study First Received: March 15, 2011
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
Post-menarchal

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Myeloproliferative Disorders
Hodgkin Disease
Leukemia
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphoma
Lymphatic Diseases
Bone Marrow Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014