Pilot Study of Lupron to Improve Immune Function After Allogeneic Bone Marrow Transplantation
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|ClinicalTrials.gov Identifier: NCT01338987|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2011
Last Update Posted : December 11, 2017
- 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 patient s. 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 lupron, a drug that lowers estrogen or testosterone levels, to see if it might improve the function of the newly transplanted cells.
- To determine whether lupron improves immune system function after bone marrow transplantation 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 FLT in imaging studies. FLT will be used to image the immune system function in patients who have received bone marrow from the donor.
- People between 15 (or as young as 9 in those who have gone through puberty) and 40 years of age. These patients must have acute myelogenous leukemia, acute lymphocytic leukemia, or high-risk myelodysplastic syndrome. They must also be eligible for a bone marrow transplant.
- Genetically similar donors for the patients who are eligible for a transplant.
- 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 lupron 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.
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome RAEB 2 Acute Lymphocytic Leukemia Acute Myelogenous Leukemia Myelodysplastic Syndrome RAEB 1||Procedure: Allogeneic HSC Transplantation Drug: Lupron Drug: 18F FLT Drug: Cyclophosphamide Drug: Methotrexate Drug: Tacrolimus Radiation: Total Body Irradiation||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Institutional Prospective Pilot Study of Lupron to Enhance Lymphocyte Immune Reconstitution Following Allogeneic Bone Marrow Transplantation in Post-Pubertal Children and Adults With Molecular Imaging Evaluation|
|Study Start Date :||April 19, 2011|
|Estimated Primary Completion Date :||November 19, 2020|
|Estimated Study Completion Date :||November 19, 2020|
Active Comparator: Arm 1
Lupron: 30 mg intramuscular injection(for adult) or 11.25 mg (for patients <18 years) between day -13 and day -20 pre-HSCT but definitely prior to initiation of preparative regimen as a 4 month intramuscular injection for patients > 18 years and as a 3 month injection (adult preparation) for patients < 18 years
Active Comparator: Arm 2
Procedure: Allogeneic HSC Transplantation
Allogeneic HSC TransplantationDrug: 18F FLT
18F FLT: 0.07 mCi/kg with a maximum of 3 mCi On day + 28 (+/- 5 days)Drug: Cyclophosphamide
Cyclophosphamide: 60 mg/kg IV on days -4 and -3 (for Adults > 22 years) or Cyclophosphamide: cyclophosphamide 50 mg/kg IV, Days -5, -4, -3, -2. (For Pediatric </= 22 years)Drug: Methotrexate
Methotrexate:10 mg/m2 IV on day +1, and 5 mg/m2 IV Days + 3, 6, 11Drug: Tacrolimus
Tacrolimus:0.02 mg/kg/day CIV on day -1.Radiation: Total Body Irradiation
Total Body Irradiation (TBI) 1200 cGy fractionate twice daily (lung block) Days -8, -7, -6, -5 (adult), -9, -8, -7, -6 (ped)
- To determine if Lupron improves B lymphocyte reconstitution after HSCT. [ Time Frame: 12 months post-transplant ]
- To assess whether 18F FLT PET/CT could predict early engraftment/immune reconstitution in marrow and thymus after allogeneic HSCT. [ Time Frame: within first 2 months post-transplant ]
- To assess safety of Lupron after 2nd HSCT and evaluate whetherFLT can predict relapse [ Time Frame: 12 months after second BMT ]
- To investigate whether Lupron will decrease the incidence of acute or chronic GVHD without altering GVT after allogeneic HSCT. [ Time Frame: years ]
- To evaluate if Lupron decreases the incidence of infections after HSCT. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338987
|United States, District of Columbia|
|Childrens National Medical Center|
|Washington, District of Columbia, United States|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, Oklahoma|
|University of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Christopher G Kanakry, M.D.||National Cancer Institute (NCI)|