Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation
Status:
Completed
Trial end date:
2020-11-19
Target enrollment:
Participant gender:
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 according to standard bone marrow
transplant (BMT) procedures.
- All women and half of the men will receive regular leuprolide doses 2 weeks before BMT
to suppress hormone function.
- All recipients will receive 4 days of radiation followed by 2-4 days of chemotherapy
before the bone marrow transplant (depending on age). Recipients will also receive other
drugs to prevent transplant rejection and other complications of transplantation.
- Recipients will be monitored in the hospital for 4 weeks after transplant with blood
tests and other studies.
- Some recipients will have an imaging study with FLT during the protocol. These imaging
studies will take place before the transplant, on days 5 and 28 after transplant, and at
a later time to be determined by the study researchers.
- Following discharge, participants will be monitored closely for up to 6 months, with
regular but less frequent followup visits for at least 5 years. Study-related
medications, including vaccinations for the new immune system, will be provided by the
National Institutes of Health during the hospital stay and after discharge.