Preservation of Ovarian Function After Hematopoietic Cell Transplant

NCT01343368 | Terminated Phase 2 Results

• 2 other identifiers: 2010LS053012M93555
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Post-menarchal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Comparison of Number of Patients Who Stopped Menstrual Bleeding

  From Baseline Through Day 365

• Comparison of Follicle Stimulating Hormone (FSH) Levels

  Baseline

• Comparison of Follicle Stimulating Hormone (FSH) Levels

  Day 100

• Comparison of Follicle Stimulating Hormone (FSH) Levels

  Day 180

• Comparison of Follicle Stimulating Hormone (FSH) Levels

  1 year

Study Arms (2)

Interventional - Received Leuprolide

EXPERIMENTAL

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.

Drug: Leuprolide; Biological: hematopoietic cell transplant

Observational Arm

ACTIVE COMPARATOR

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.

Biological: reduced intensity allogeneic HCT

Interventions

Leuprolide 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

Also known as: Lupron Depot-3(R), Leuprolide acetate

Interventional - Received Leuprolide

hematopoietic cell transplant BIOLOGICAL

Conventional bone marrow transplant regimen.

Also known as: HCT

Interventional - Received Leuprolide

reduced intensity allogeneic HCT 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.

Also known as: RIC

Observational Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• Minnesota Medical Foundation: collaborator

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

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

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. Angela Smith
• Organization: Masonic Cancer Center, University of Minnesota

smith719@umn.edu

612-626-8094

Study Officials

• Angela Smith, M.D.

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: April 28, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 5, 2017
• Results First Posted: July 17, 2017

Record last verified: 2017-12

Locations

US (1)