Clinical trial NCT01343368: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Non-Hodgkin Lymphoma
Hodgkin Disease
Acute Myeloid Leukemia
Myeloproliferative Disorders
Keywords: Post-menarchal
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: Minnesota Medical Foundation
First posted: 2011-04-28
Enrollment: 19
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Comparison of Number of Patients With Ovarian Failure
timeFrame: Through Day 180 Post Transplant
Secondary outcomes:
measure: Comparison of Number of Patients Who Stopped Menstrual Bleeding
timeFrame: From Baseline Through Day 365
measure: Comparison of Follicle Stimulating Hormone (FSH) Levels
timeFrame: Baseline
measure: Comparison of Follicle Stimulating Hormone (FSH) Levels
timeFrame: Day 100
measure: Comparison of Follicle Stimulating Hormone (FSH) Levels
timeFrame: Day 180
measure: Comparison of Follicle Stimulating Hormone (FSH) Levels
timeFrame: 1 year
measure: Comparison of Follicle Stimulating Hormone (FSH) Levels
timeFrame: 2 years
measure: Comparison of Number of Patients Who Resumed Menstrual Cycles
timeFrame: Day 365 Post Transplant
measure: Comparison of Lutineizing Hormone (LH) Levels
timeFrame: Baseline
measure: Comparison of Luteinizing Hormone (LH) Levels
timeFrame: Day 100
measure: Comparison of Luteinizing Hormone (LH) Levels
timeFrame: Day 180
measure: Comparison of Luteinizing Hormone (LH) Levels
timeFrame: 1 year
measure: Comparison of Leuprolide Hormone (LH) Levels
timeFrame: 2 years
measure: Comparison of Antimullerian Hormone (AMH) Levels After Transplant
timeFrame: Day Prior to Transplant
measure: Comparison of Antimullerian Hormone (AMH) Levels After Transplant
timeFrame: Day 180 after Transplant
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Angela Smith, M.D.
role: PRINCIPAL_INVESTIGATOR
References: