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

March 15, 2011
May 15, 2014
July 2011
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01343368 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Preservation of Ovarian Function After Hematopoietic Cell Transplant
A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Multiple Myeloma
  • Non-Hodgkin Lymphoma
  • Hodgkin Disease
  • Acute Myeloid Leukemia
  • Myeloproliferative Disorders
  • 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
  • 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
  • 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.
    Interventions:
    • Drug: Leuprolide
    • Biological: hematopoietic cell transplant
  • 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.
    Intervention: Biological: reduced intensity allogeneic HCT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
47
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Female
50 Years and older
No
Contact: Angela Smith, M.D. 612-626-2778 smith719@umn.edu
United States
 
NCT01343368
2010LS053, 012M93555
No
Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Minnesota Medical Foundation
Principal Investigator: Angela Smith, M.D. Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP