Clinical trial · Interventional
Preservation of Ovarian Function After Hematopoietic Cell Transplant
A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)
NCT01343368CI-TRIAL-00030659terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hematopoietic cell transplant | Biological | — | UNRESOLVED |
| Leuprolide | Drug | Leuprolide | ALIAS |
| reduced intensity allogeneic HCT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional - Received Leuprolide
- description
- 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.
- interventionNames
- Drug: Leuprolide
- Biological: hematopoietic cell transplant
- type
- ACTIVE_COMPARATOR
- label
- Observational Arm
- description
- 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.
- interventionNames
- Biological: reduced intensity allogeneic HCT
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.