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

University of Oklahoma (OU)

Status: Completed

Conditions: Hematological Neoplasms; Hematopoietic Stem Cell Transplantation

Treatments: Drug: Busulfex, Fludarabine, ALemtuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00582894

IRB #11835 (Other Identifier)

Reduced-Intensity

Details and patient eligibility

About

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

Full description

Primary Endpoints:

1. Engraftment of donor cells
2. Regimen related toxicities

Secondary Endpoints:

1. Disease-free survival
2. Overall survival

Enrollment: 17 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

A

Other group

Description:

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

Treatment:

Drug: Busulfex, Fludarabine, ALemtuzumab