drugset / Trial / NCT01158885
Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia
Phase 2
Terminated
2 enrolled
Therapeutic Advances in Childhood Leukemia Consortium
Genzyme, a Sanofi Company · collab
NaSingle-groupOpen-labelTreatment
Summary
This study will test the ability of clofarabine + cytarabine to eliminate minimal residual disease (MRD) in acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) patients whose bone marrows exhibit complete remission by morphology. The toxicity profile of this regimen will be evaluated in addition to toxicity experienced by patients who proceed to stem cell transplant. Overall length of remission will also be collected.
Timeline
- Start
- 2010-08
- Primary completion
- 2012-10-24
- Completion
- 2012-10-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clofarabine | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 30 mg | Intravenous |
| Subject | Cytarabine | Small molecule | 50 mg | Intravenous |
| Subject | Cytarabine | Small molecule | 70 mg | Intravenous |
| Subject | Cytarabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 8 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 10 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 12 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 15 mg | Intrathecal |