NCT00066417

Peripheral Stem Cell Transplant in Treating Patients With High-Risk Leukemia

Pilot Study Of T-Cell-Depleted Peripheral Blood Stem Cell Transplantation From Partially Matched Related Donors For Patients With High-Risk Leukemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: All
• Age: 10 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Myelodysplastic/Myeloproliferative Diseases

Interventions

Type	Name	Description
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

Timeline

• Completion: 2007-01-01
• First posted: 2003-08-07
• Last updated: 2013-05-01

Locations

1 site across 1 country: United States