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Preservation of Ovarian Function After Hematopoietic Cell Transplant

Information source: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma; Non-Hodgkin Lymphoma; Hodgkin Disease; Acute Myeloid Leukemia; Myeloproliferative Disorders

Intervention: Leuprolide (Drug); hematopoietic cell transplant (Biological); reduced intensity allogeneic HCT (Biological)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Masonic Cancer Center, University of Minnesota

Official(s) and/or principal investigator(s):
Angela Smith, M.D., Principal Investigator, Affiliation: Masonic Cancer Center, University of Minnesota

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.

Clinical Details

Official title: A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Comparison of Number of Patients with Ovarian Failure

Secondary outcome:

Comparison of Number of Participants Who Stopped Menstrual Bleeding

Comparison of Follicle Stimulating Hormone (FSH) Levels

Comparison of Number of Participants Who Resumed Menstrual Cycles

Comparison of Leuprolide Hormone (LH) Levels

Comparison of Antimullerian Hormone (AMH) Levels After Transplant

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota 55455, United States
Additional Information

Starting date: July 2011
Last updated: April 22, 2015

Page last updated: August 23, 2015

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