drugset / Trial / NCT00477542
A Phase I Trial of Myeloablative Conditioning w/ Clofarabine and HD Busulfan for Pts w/ Refractory Heme Malignancies Undergoing Allo PBSCT
NaSingle-groupOpen-labelTreatment
Summary
This is a phase trial to determine the maximum tolerated dose (MTD) of clofarabine in a combination with a myeloablative dose of busulfan. This is an initial step in developing a novel myeloablative preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT). While this phase I trial will initially develop the regimen in patients with refractory disease, it is expected that it will find its best application in patients with less advanced disease
Timeline
- Start
- 2007-05
- Primary completion
- 2010-11
- Completion
- 2010-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clofarabine | Other / unclassified | 20 mg/m2 | — |
| Subject | Clofarabine | Other / unclassified | 30 mg/m2 | — |
| Subject | Clofarabine | Other / unclassified | 40 mg/m2 | — |
| Subject | Clofarabine | Other / unclassified | 50 mg/m2 | — |
| Subject | Clofarabine | Other / unclassified | 60 mg/m2 | — |
| Subject | Clofarabine | Other / unclassified | 70 mg/m2 | — |