Clinical trial · Interventional
Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support
Phase I/II Trial of Fludarabine in Combination With Intravenous Busulfan and Allogeneic Progenitor Cell Support for Patients With Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Busulfan + Fludarabine
- description
- Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m\^2 IV daily for 4 days.
- interventionNames
- Drug: Busulfan
- Drug: Fludarabine
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- 1 month
- description
- Continual reassessment method (four times a day) used to determine an MTD, with a target toxicity probability of 20%, where "toxicity" is defined as grade 3 or 4 conventional toxicity \[National Cancer Institute Common Toxicity Criteria (NCI-CTC)\]. Participant evaluation in a cohort with each modality is 30 days.
Secondary outcomes (1)
- measure
- Number of Participants With Graft Versus Host Disease (GVHD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available