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

Completed · Phase 1/Phase 2

Conditions studied: Hematologic Malignancies

In brief

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.

Key facts

Study ID

NCT00506857

Run by

M.D. Anderson Cancer Center

People needed

82

Starts

2003-11-01

Expected to finish

2011-08-01

Last updated by the study team

2012-02-28

Who can join

Age: any, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Less than physiologic 75 years of age.
• Interferon resistant late chronic phase CML not eligible for a protocol of higher priority.
• Accelerated/Blastic Phase CML.
• Acute leukemia or Intermediate to High Risk MDS according to the IPPS.
• Any Lymphoma or Myeloma beyond CR1 ineligible for a protocol of higher priority.
• Patients must have an HLA compatible donor willing to donate either peripheral blood or bone marrow progenitor cells.
• Both patients and donor must sign written informed consents.

You may not qualify if…

• Uncontrolled infection
• Bilirubin >3.0
• Creatinine >2.5
• Performance Status >Zubrod 2

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.