Preservation of Ovarian Function After Hematopoietic Cell Transplant
Stopped early · Phase 2
Conditions studied: Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Disease, Acute Myeloid Leukemia, Myeloproliferative Disorders
In brief
Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.
Key facts
- Study ID
- NCT01343368
- Run by
- Masonic Cancer Center, University of Minnesota
- People needed
- 19
- Starts
- 2011-07-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2017-12-05
Who can join
Age: 50 and older. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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