Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases

Not Applicable

Completed

• Conditions: Hematological Neoplasms; Hematopoietic Stem Cell Transplantation
• Interventions: Drug: Busulfex, Fludarabine, ALemtuzumab

• Registration Number: NCT00582894
• Lead Sponsor: University of Oklahoma

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

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2007-12-28
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2011-01-10
• Status Verified: 2011-03
• Results First Submitted QC: 2011-03-23
• Last Update Submitted: 2011-03-23
• Results First Posted: 2011-04-22
• Last Update Posted: 2011-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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Exclusion Criteria

• Does not meet the above Inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Busulfex, Fludarabine, ALemtuzumab	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

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Transplant Related Mortality (TRM)	At Day 100 post trans-plant
Number of Participants Experiencing Engraftment Donor Chimerism (EDC)	At time of study termination

Secondary Outcome Measures

Name	Time	Method
Number of Participants Relapse-Free	100 days post-transplant
Number of Participants Overall Survival as a Function of Time.	100 days post transplant

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States