NCT01343368

Preservation of Ovarian Function After Hematopoietic Cell Transplant

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2011-04-28
• Last updated: 2017-12-05
• Results posted: 2017-07-17

Locations

1 site across 1 country: United States