Preservation of Ovarian Function After Hematopoietic Cell Transplant

• Status: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborator: Minnesota Medical Foundation
• Treatments: Leuprolide

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.