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Preservation of Ovarian Function After Hematopoietic Cell Transplant

Primary Purpose

Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Leuprolide
hematopoietic cell transplant
reduced intensity allogeneic HCT
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring Post-menarchal

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Masonic Cancer Center, University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional - Received Leuprolide

Observational Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Comparison of Follicle Stimulating Hormone (FSH) Levels
Comparison of treatment arms; interventional versus observational average FSH levels.
Comparison of Follicle Stimulating Hormone (FSH) Levels
Comparison of treatment arms; interventional versus observational average FSH levels.
Comparison of Follicle Stimulating Hormone (FSH) Levels
Comparison of treatment arms; interventional versus observational average FSH levels.
Comparison of Follicle Stimulating Hormone (FSH) Levels
Comparison of treatment arms; interventional versus observational average FSH levels.
Comparison of Follicle Stimulating Hormone (FSH) Levels
Comparison of treatment arms; interventional versus observational average FSH levels.
Comparison of Number of Patients Who Resumed Menstrual Cycles
Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant
Comparison of Lutineizing Hormone (LH) Levels
Comparison of treatment arms; interventional versus observational average LH levels during study.
Comparison of Luteinizing Hormone (LH) Levels
Comparison of treatment arms; interventional versus observational average LH levels during study.
Comparison of Luteinizing Hormone (LH) Levels
Comparison of treatment arms; interventional versus observational average LH levels during study.
Comparison of Luteinizing Hormone (LH) Levels
Comparison of treatment arms; interventional versus observational average LH levels during study.
Comparison of Leuprolide Hormone (LH) Levels
Comparison of treatment arms; interventional versus observational average LH levels during study.
Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.

Full Information

First Posted
March 15, 2011
Last Updated
December 3, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Minnesota Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01343368
Brief Title
Preservation of Ovarian Function After Hematopoietic Cell Transplant
Official Title
A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Minnesota Medical Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Disease, Acute Myeloid Leukemia, Myeloproliferative Disorders
Keywords
Post-menarchal

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional - Received Leuprolide
Arm Type
Experimental
Arm Description
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.
Arm Title
Observational Arm
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Leuprolide
Other Intervention Name(s)
Lupron Depot-3(R), Leuprolide acetate
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
hematopoietic cell transplant
Other Intervention Name(s)
HCT
Intervention Description
Conventional bone marrow transplant regimen.
Intervention Type
Biological
Intervention Name(s)
reduced intensity allogeneic HCT
Other Intervention Name(s)
RIC
Intervention Description
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 Outcome Measure Information:
Title
Comparison of Number of Patients With Ovarian Failure
Description
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 Outcome Measure Information:
Title
Comparison of Number of Patients Who Stopped Menstrual Bleeding
Description
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
Title
Comparison of Follicle Stimulating Hormone (FSH) Levels
Description
Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame
Baseline
Title
Comparison of Follicle Stimulating Hormone (FSH) Levels
Description
Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame
Day 100
Title
Comparison of Follicle Stimulating Hormone (FSH) Levels
Description
Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame
Day 180
Title
Comparison of Follicle Stimulating Hormone (FSH) Levels
Description
Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame
1 year
Title
Comparison of Follicle Stimulating Hormone (FSH) Levels
Description
Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame
2 years
Title
Comparison of Number of Patients Who Resumed Menstrual Cycles
Description
Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant
Time Frame
Day 365 Post Transplant
Title
Comparison of Lutineizing Hormone (LH) Levels
Description
Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame
Baseline
Title
Comparison of Luteinizing Hormone (LH) Levels
Description
Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame
Day 100
Title
Comparison of Luteinizing Hormone (LH) Levels
Description
Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame
Day 180
Title
Comparison of Luteinizing Hormone (LH) Levels
Description
Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame
1 year
Title
Comparison of Leuprolide Hormone (LH) Levels
Description
Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame
2 years
Title
Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Description
Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
Time Frame
Day Prior to Transplant
Title
Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Description
Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
Time Frame
Day 180 after Transplant

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Smith, M.D.
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Preservation of Ovarian Function After Hematopoietic Cell Transplant

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