drugset / Trial / NCT02085408
Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Phase 3
Completed
727 enrolled
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.
Timeline
- Start
- 2011-02-04
- Primary completion
- 2021-02-22
- Completion
- 2022-12-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clofarabine | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 30 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 1500 mg/m2 | Intravenous |
| Comparator | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
Indications
acute erythroid leukemia
acute megakaryoblastic leukemia in adult
acute myeloblastic leukemia with maturation
acute myeloblastic leukemia without maturation
acute myeloid leukemia with 11q23 abnormalities
acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22)
acute myeloid leukemia with minimal differentiation
acute myeloid leukemia with multilineage dysplasia
acute myeloid leukemia with t(8;21)(q22;q22) translocation
acute myeloid leukemia, del(5q31-q32)
acute myeloid leukemia, t(16;16)(p13.1;q22)
acute myelomonocytic leukemia M4
adult acute monocytic leukemia