drugset / Trial / NCT00577694
Clofarabine and Gemtuzumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Phase 1
Terminated
21 enrolled
UNC Lineberger Comprehensive Cancer Center
Genzyme, a Sanofi Company · collabNational Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving clofarabine together with gemtuzumab may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with gemtuzumab in treating patients with relapsed or refractory acute myeloid leukemia.
Timeline
- Start
- 2007-11
- Primary completion
- 2010-07
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clofarabine | Other / unclassified | 20 mg/m2 | Intravenous |
| Background | Gemtuzumab Ozogamicin | Monoclonal antibody | 3 mg/m2 | Intravenous |