Phase 2
Completed N=80
Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support
Source: ClinicalTrials.gov NCT00506857 ↗Enrolled (actual)
80
Serious AEs
90.0%
Results posted
Feb 2012
Primary outcomePrimary: Maximum Tolerated Dose (MTD) — 11.2 mg/kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
11.2 | — |
| SECONDARY Number of Participants With Graft Versus Host Disease (GVHD) |
18; 8 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Uncontrolled infection
- Bilirubin >3.0
- Creatinine >2.5
- Performance Status >Zubrod 2
Data sourced from ClinicalTrials.gov (NCT00506857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.