Preservation of Ovarian Function After Hematopoietic Cell Transplant

NCT01343368 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-12-05

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Minnesota Medical Foundation

    collaborator OTHER
  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Angela Smith, M.D. · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01343368 on ClinicalTrials.gov