Preservation of Ovarian Function After Hematopoietic Cell Transplant

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01343368
• Other study ID #: 2010LS053
• Secondary ID: 012M93555
• Status: Terminated
• Phase: Phase 2
• First received: March 15, 2011
• Last updated: December 3, 2017
• Start date: July 2011
• Est. completion date: April 2015

Study information

• Verified date: December 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Hodgkin Disease
• Leukemia, Myeloid, Acute
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Myeloproliferative Disorders
• Non-Hodgkin Lymphoma

Intervention

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

Biological:
• hematopoietic cell transplant
Conventional bone marrow transplant regimen.
• 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.

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota	Minnesota Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through Day 180 Post Transplant
Secondary	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	From Baseline Through Day 365
Secondary	Comparison of Follicle Stimulating Hormone (FSH) Levels	Comparison of treatment arms; interventional versus observational average FSH levels.	Baseline
Secondary	Comparison of Follicle Stimulating Hormone (FSH) Levels	Comparison of treatment arms; interventional versus observational average FSH levels.	Day 100
Secondary	Comparison of Follicle Stimulating Hormone (FSH) Levels	Comparison of treatment arms; interventional versus observational average FSH levels.	Day 180
Secondary	Comparison of Follicle Stimulating Hormone (FSH) Levels	Comparison of treatment arms; interventional versus observational average FSH levels.	1 year
Secondary	Comparison of Follicle Stimulating Hormone (FSH) Levels	Comparison of treatment arms; interventional versus observational average FSH levels.	2 years
Secondary	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	Day 365 Post Transplant
Secondary	Comparison of Lutineizing Hormone (LH) Levels	Comparison of treatment arms; interventional versus observational average LH levels during study.	Baseline
Secondary	Comparison of Luteinizing Hormone (LH) Levels	Comparison of treatment arms; interventional versus observational average LH levels during study.	Day 100
Secondary	Comparison of Luteinizing Hormone (LH) Levels	Comparison of treatment arms; interventional versus observational average LH levels during study.	Day 180
Secondary	Comparison of Luteinizing Hormone (LH) Levels	Comparison of treatment arms; interventional versus observational average LH levels during study.	1 year
Secondary	Comparison of Leuprolide Hormone (LH) Levels	Comparison of treatment arms; interventional versus observational average LH levels during study.	2 years
Secondary	Comparison of Antimullerian Hormone (AMH) Levels After Transplant	Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.	Day Prior to Transplant
Secondary	Comparison of Antimullerian Hormone (AMH) Levels After Transplant	Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.	Day 180 after Transplant