drugset / Trial / NCT00446173
Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia
NaSingle-groupOpen-labelTreatment
Summary
Primary Objective: 1\. To study ex-vivo purging of autologous hematopoietic stem cells that will be used to support high-dose chemotherapy in patients with chronic myelogenous leukemia (CML). Major endpoints are neutrophil engraftment and survival. Secondary Objectives: 1. To evaluate the toxicity of ex-vivo purged autologous cells when used to support high-dose chemotherapy. 2. To evaluate the rate and duration of cytogenetic remissions achieved with this strategy. 3. To determine the time to platelet recovery to 20,000/mm3. 4. To determine the one-year survival rate.
Timeline
- Start
- 2007-03
- Primary completion
- 2009-01
- Completion
- 2009-01
Outcome
Outcome not reported
Stopped (Enrollment): “Terminated due to low accrual.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | G-CSF | Unknown | 10 ug/kg | Subcutaneous |
| Background | GM-CSF | Protein / enzyme biologic | 250 ug/kg | Subcutaneous |