Preservation of Ovarian Function After Hematopoietic Cell Transplant

NCT ID: NCT01343368

Last Updated: 2017-12-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-04-30

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.

Conditions

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

Keywords

Post-menarchal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interventional - Received Leuprolide

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.

Group Type: EXPERIMENTAL

Leuprolide

Intervention Type: DRUG

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

hematopoietic cell transplant

Intervention Type: BIOLOGICAL

Conventional bone marrow transplant regimen.

Observational Arm

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.

Group Type: ACTIVE_COMPARATOR

reduced intensity allogeneic HCT

Intervention Type: BIOLOGICAL

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.

Interventions

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

Intervention Type: DRUG

hematopoietic cell transplant

Conventional bone marrow transplant regimen.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Lupron Depot-3(R); Leuprolide acetate; HCT; RIC

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Minnesota Medical Foundation

OTHER

Sponsor Role: collaborator

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela Smith, M.D.

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

012M93555

Identifier Type: OTHER

Identifier Source: secondary_id

2010LS053

Identifier Type: -

Identifier Source: org_study_id