Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

1. To determine the relative toxicities, engraftment potential, kinetics of engraftment, degree of chimerism and disease control achieved with the combination of fludarabine and busulfan at different dose levels and different dose schedules in patients undergoing allogeneic stem cell transplant (SCT).

2. Determine pharmacokinetics, and toxicity of intravenous busulfan given at equal total dose levels given four times daily, or once daily.

3. In vivo determination of fludarabine inhibitory effects on DNA repair.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Busulfan; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

Inclusion Criteria:

1. Less than physiologic 75 years of age.

2. Interferon resistant late chronic phase CML not eligible for a protocol of higher priority.

3. Accelerated/Blastic Phase CML.

4. Acute leukemia or Intermediate to High Risk MDS according to the IPPS.

5. Any Lymphoma or Myeloma beyond CR1 ineligible for a protocol of higher priority.

6. Patients must have an HLA compatible donor willing to donate either peripheral blood or bone marrow progenitor cells.

7. Both patients and donor must sign written informed consents.

Exclusion Criteria:

1. Uncontrolled infection

2. Bilirubin >3.0

3. Creatinine >2.5

4. Performance Status >Zubrod 2