Experimental Bone Marrow Transplant Protocol
Completed · Phase 2
Conditions studied: Acute Lymphocytic Leukemia, Chronic Myeloid Leukemia, Acute Myelocytic Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders
In brief
Bone marrow transplantation (BMT) is a risky procedure. If doctors could reduce the complications, BMT would be safer to use for a wider range of conditions. The purposes of this study are * to prevent graft rejection by increasing the amount of immunosuppression and by giving some lymphocytes from the donor before transplant; * to prevent graft-versus-host disease (GVHD) by transplanting T-cell depleted stem cells; * to improve the immune effect against residual leukemia by the add-back of donor lymphocytes before transplant and six or more weeks after transplant. Beyond the standard transplant protocol, study participants will undergo additional procedures. First, along with total body irradiation, patients will receive two drugs (a high dose of cyclophosphamide and fludarabine) to suppress immunity and prevent rejection of the transplant. Second, four days before the transplant, patients will be given donor lymphocytes that have been irradiated to make them incapable of causing GVHD. On the day of the transplant, patients will receive an infusion of T-cell depleted bone marrow stem cells. Finally, patients will receive two doses of add-back donor T-cells (45 and 100 days post transplant) and the immunosuppressive drug cyclosporine starting on day 44 until about six months after transplant. Study participants must be between the ages of 10 and 56 and have a family member who is a suitable stem cell donor match.
Key facts
- Study ID
- NCT00061581
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 14
- Starts
- 2003-05-19
- Expected to finish
- 2017-06-14
- Last updated by the study team
- 2018-09-26
Who can join
Age: 10 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Donor (any of the following)
- Pregnant or lactating
- Donor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of congestive heart failure or unstable angina, thrombocytopenia)
- HIV positive. Donors who are positive for HBV, HCV or HTLV-1 may be used if the risk-benefit ratio is considered acceptable by the patient and investigator.
- Weight less than 18 kg
- Age less than 2 or greater than 80 years
- Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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