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NCT01338987 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT01338987: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01338987 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 76 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01338987, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
Background: * One way to treat certain cancers of the blood and immune system is to give a patient stem cells from the bone marrow of a donor whose genes are very similar but not identical to the patients. One problem with these transplants is that the new immune cells may not work as well in the recipient as they did in the donor. The result may be that the immune system will not work as well. This can increase the risk of severe infections and other complications. * Researchers are studying the use of drugs that lower hormone levels and may allow the immune system to recover in a way that improves white blood cell function. In this study they will be looking at the drug leuprolide, a drug that lowers estrogen or testosterone levels, to see if it might improve the function of the newly transplanted cells. Objectives: * To determine whether leuprolide improves immune system function after bone marrow transplant from a donor with similarities in their immune cells (matched to each other). * To evaluate the effectiveness of a nuclear medicine test with a radiotracer drug 3-deoxy-3 18F-fluorothymidine (FLT) in imaging studies. FLT will be used to image the immune system function in patients who have received bone marrow from the donor. Eligibility: * People between 15 (or as young as 9 in those who have gone through puberty) and 55 years of age. These patients must have acute myelogenous leukemia, acute lymphocytic leukemia, high-risk myelodysplastic syndrome, chronic myelomonocytic leukemia, or chronic myeloid leukemia. They must also be eligible for a bone marrow transplant. * Genetically similar donors for the patients who are eligible for a transplant. Design: * People taking part in the study will be screened with a physical examination, medical history, blood and urine tests, and imaging studies. Patients who are not in remission or who require a bone marrow donor search may receive chemotherapy first. * Donors will provide bone marrow for transplant accor
Interventions
- DRUG Cyclophosphamide
- DRUG Methotrexate
- DRUG Leuprolide
- PROCEDURE First Allogeneic Bone Marrow Transplant (BMT)
- DRUG 18F FLT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2011-04-19 |
| Est. Completion | 2020-11-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01338987
The ClinicalTrials.gov registry entry for NCT01338987 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01338987 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01338987 about?
NCT01338987 is a clinical study titled "Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation". Background: * One way to treat certain cancers of the blood and immune system is to give a patient stem cells from the bone marrow of a donor whose genes are very similar but not identical to the patients. One problem with these transplants is that the new immune cells may not work as well in the r...
What is the current status of trial NCT01338987?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2011-04-19. Estimated completion is 2020-11-19.
What interventions are being tested in trial NCT01338987?
The interventions under investigation include: Cyclophosphamide (DRUG), Methotrexate (DRUG), Leuprolide (DRUG), First Allogeneic Bone Marrow Transplant (BMT) (PROCEDURE), 18F FLT (DRUG).
Who is sponsoring clinical trial NCT01338987?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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