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Preservation of Ovarian Function After Hematopoietic Cell Transplant

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ClinicalTrials.gov Identifier: NCT01343368
Recruitment Status : Terminated
First Posted : April 28, 2011
Results First Posted : July 17, 2017
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date  ICMJE March 15, 2011
First Posted Date  ICMJE April 28, 2011
Results First Submitted Date June 19, 2017
Results First Posted Date July 17, 2017
Last Update Posted Date December 5, 2017
Study Start Date  ICMJE July 2011
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
Comparison of Number of Patients With Ovarian Failure [ Time Frame: Through Day 180 Post Transplant ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
Comparison of Number of Patients With Ovarian Failure [ Time Frame: Day 180 Post Transplant ]
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.
Change History Complete list of historical versions of study NCT01343368 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
  • Comparison of Number of Patients Who Stopped Menstrual Bleeding [ Time Frame: From Baseline Through Day 365 ]
    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 ]
    Comparison of treatment arms; interventional versus observational average FSH levels.
  • Comparison of Follicle Stimulating Hormone (FSH) Levels [ Time Frame: Day 100 ]
    Comparison of treatment arms; interventional versus observational average FSH levels.
  • Comparison of Follicle Stimulating Hormone (FSH) Levels [ Time Frame: Day 180 ]
    Comparison of treatment arms; interventional versus observational average FSH levels.
  • Comparison of Follicle Stimulating Hormone (FSH) Levels [ Time Frame: 1 year ]
    Comparison of treatment arms; interventional versus observational average FSH levels.
  • Comparison of Follicle Stimulating Hormone (FSH) Levels [ Time Frame: 2 years ]
    Comparison of treatment arms; interventional versus observational average FSH levels.
  • Comparison of Number of Patients Who Resumed Menstrual Cycles [ Time Frame: Day 365 Post Transplant ]
    Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant
  • Comparison of Lutineizing Hormone (LH) Levels [ Time Frame: Baseline ]
    Comparison of treatment arms; interventional versus observational average LH levels during study.
  • Comparison of Luteinizing Hormone (LH) Levels [ Time Frame: Day 100 ]
    Comparison of treatment arms; interventional versus observational average LH levels during study.
  • Comparison of Luteinizing Hormone (LH) Levels [ Time Frame: Day 180 ]
    Comparison of treatment arms; interventional versus observational average LH levels during study.
  • Comparison of Luteinizing Hormone (LH) Levels [ Time Frame: 1 year ]
    Comparison of treatment arms; interventional versus observational average LH levels during study.
  • Comparison of Leuprolide Hormone (LH) Levels [ Time Frame: 2 years ]
    Comparison of treatment arms; interventional versus observational average LH levels during study.
  • Comparison of Antimullerian Hormone (AMH) Levels After Transplant [ Time Frame: Day Prior to Transplant ]
    Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
  • Comparison of Antimullerian Hormone (AMH) Levels After Transplant [ Time Frame: Day 180 after Transplant ]
    Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
  • Comparison of Number of Participants Who Stopped Menstrual Bleeding [ Time Frame: From Baseline Through Day 365 ]
    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 ]
    Comparison of treatment arms; interventional versus observational average FSH levels.
  • Comparison of Antimullerian Hormone (AMH) Levels After Transplant [ Time Frame: Baseline, Day 180 ]
    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 ]
    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 ]
    Comparison of treatment arms; interventional versus observational average LH levels during study.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Preservation of Ovarian Function After Hematopoietic Cell Transplant
Official Title  ICMJE A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Multiple Myeloma
  • Non-Hodgkin Lymphoma
  • Hodgkin Disease
  • Acute Myeloid Leukemia
  • Myeloproliferative Disorders
Intervention  ICMJE
  • 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
Study Arms
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 19, 2017)
19
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2011)
38
Actual Study Completion Date April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01343368
Other Study ID Numbers  ICMJE 2010LS053
012M93555 ( Other Identifier: Institutional Review Board, University of Minnesota )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Minnesota Medical Foundation
Investigators  ICMJE
Principal Investigator: Angela Smith, M.D. Masonic Cancer Center, University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date December 2017

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