Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Busulfex, Fludarabine, ALemtuzumab
- Conditions
- Hematological Neoplasms
- Sponsor
- University of Oklahoma
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Number of Participants Experiencing Transplant Related Mortality (TRM)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases
Detailed Description
Primary Endpoints: 1. Engraftment of donor cells 2. Regimen related toxicities Secondary Endpoints: 1. Disease-free survival 2. Overall survival
Investigators
Eligibility Criteria
Inclusion Criteria
- •Performance status 0-2
- •Ejection fraction \> 30%
- •AST/ALT and bilirubin not \> 4 times normal
- •Creatinine clearance greater than 70 ml/min.
- •FEV1 greater than 1.0 and diffusion capacity greater than 40%
- •Age 18-75 years
- •Patients must be at high risk for conventional regimen related toxicity
- •Malignant hematologic disease that would otherwise be considered treatable with ASCT
Exclusion Criteria
- •Does not meet the above Inclusion criteria
Arms & Interventions
A
Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Intervention: Busulfex, Fludarabine, ALemtuzumab
Outcomes
Primary Outcomes
Number of Participants Experiencing Transplant Related Mortality (TRM)
Time Frame: At Day 100 post trans-plant
Number of Participants Experiencing Engraftment Donor Chimerism (EDC)
Time Frame: At time of study termination
Secondary Outcomes
- Number of Participants Relapse-Free(100 days post-transplant)
- Number of Participants Overall Survival as a Function of Time.(100 days post transplant)