Peripheral Stem Cell Transplant in Treating Patients With High-Risk Leukemia
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|ClinicalTrials.gov Identifier: NCT00066417|
Recruitment Status : Terminated (Trial was withdrawn for drug availability issues.)
First Posted : August 7, 2003
Last Update Posted : May 1, 2013
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in treating patients with high-risk leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloproliferative Disorders Leukemia Myelodysplastic/Myeloproliferative Diseases||Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: methylprednisolone Drug: therapeutic allogeneic lymphocytes Drug: thiotepa Procedure: allogeneic bone marrow transplantation Procedure: biological therapy Procedure: bone marrow ablation with stem cell support Procedure: bone marrow transplantation Procedure: chemotherapy Procedure: leukocyte therapy Procedure: non-specific immune-modulator therapy Procedure: peripheral blood lymphocyte therapy Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy||Phase 2|
- Determine the safety of a preparative regimen comprising total body irradiation, cyclophosphamide, thiotepa, and fludarabine, but without anti-thymocyte globulin, in patients with high-risk leukemia treated with peripheral blood stem cell transplantation from partially matched related donors.
- Determine the incidence of graft failure, acute graft-versus-host disease (GVHD), and treatment-related mortality in patients treated with this regimen.
- Determine rates of chronic GVHD and relapse in patients treated with this regimen.
- Determine disease-free and overall survival in patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive a preparative regimen comprising total lymphoid irradiation once daily on days -13 to -11; cyclophosphamide IV over 1 hour on days -8 and -7; thiotepa IV over 4 hours every 12 hours on day -6; fludarabine IV over 30 minutes on days -5 to -1; and total body irradiation once on day -1. Patients also receive cyclosporine IV over 12 hours on days -8 to -1 and methylprednisolone IV twice daily on days -3 and -2. Patients receive CD34-enriched T-cell-depleted allogeneic stem cell infusion on day 0.
Patients with disease progression or uncontrolled infection but without grade II or greater graft-versus-host disease may receive up to 3 donor lymphocyte infusions at least 4 weeks apart until disease regression.
Patients are followed at least weekly until day 100 and then at 6, 12, 18, 24, 36, and 48 months.
PROJECTED ACCRUAL: A total of 20-51 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Of T-Cell-Depleted Peripheral Blood Stem Cell Transplantation From Partially Matched Related Donors For Patients With High-Risk Leukemia|
|Actual Study Completion Date :||January 2007|
- Incidence of graft failure 100 days post-transplant
- Incidence of acute and chronic graft-vs-host disease100 days post-transplant
- Transplant-related mortality 100 days post-transplant
- Disease-free survival 100 days post-transplant
- Overall survival 100 days post-transplant
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): NCT00066417
|United States, Maryland|
|NIH - Warren Grant Magnuson Clinical Center|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Bipin N. Savani, MD||National Heart, Lung, and Blood Institute (NHLBI)|