drugset / Trial / NCT00703820
Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia
Phase 3
Completed
324 enrolled
St. Jude Children's Research Hospital
Genzyme, a Sanofi Company · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the feasibility and efficacy of a novel form of therapy-haploidentical NK cell transplantation-in patients with standard-risk AML. In addition, we will investigate the efficacy of clofarabine + cytarabine (Clo/AraC) in newly diagnosed patients with AML and attempt to optimize outcome through the use of MRD-adapted therapy and further improvements in supportive care.
Timeline
- Start
- 2008-08-04
- Primary completion
- 2017-03-30
- Completion
- 2020-08-14
Publications
- Rubnitz JE, Lacayo NJ, Inaba H, Heym K, Ribeiro RC, Taub J, McNeer J, Degar B, Schiff D, Yeoh AE, Coustan-Smith E, Wang L, Triplett B, Raimondi SC, Klco J, Choi J, Pounds S, Pui CH. Clofarabine Can Replace Anthracyclines and Etoposide in Remission Induction Therapy for Childhood Acute Myeloid Leukemia: The AML08 Multicenter, Randomized Phase III Trial. J Clin Oncol. 2019 Aug 10;37(23):2072-2081. doi: 10.1200/JCO.19.00327. Epub 2019 Jun 27.
- Nguyen R, Wu H, Pounds S, Inaba H, Ribeiro RC, Cullins D, Rooney B, Bell T, Lacayo NJ, Heym K, Degar B, Schiff D, Janssen WE, Triplett B, Pui CH, Leung W, Rubnitz JE. A phase II clinical trial of adoptive transfer of haploidentical natural killer cells for consolidation therapy of pediatric acute myeloid leukemia. J Immunother Cancer. 2019 Mar 20;7(1):81. doi: 10.1186/s40425-019-0564-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clofarabine | Other / unclassified | 52 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 6 mg | Intravenous |
| Comparator | Cytarabine | Small molecule | 8 mg | Intravenous |
| Comparator | Cytarabine | Small molecule | 10 mg | Intravenous |
| Comparator | Cytarabine | Small molecule | 12 mg | Intravenous |
| Comparator | Cytarabine | Small molecule | 18 mg | Intravenous |
| Comparator | Cytarabine | Small molecule | 24 mg | Intravenous |
| Comparator | Cytarabine | Small molecule | 30 mg | Intravenous |
| Comparator | Cytarabine | Small molecule | 36 mg | Intravenous |
| Comparator | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 3000 mg/m2 | Intravenous |
| Comparator | Daunorubicin | Small molecule | 1.67 mg/kg | Intravenous |
| Comparator | Daunorubicin | Small molecule | 50 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | Intravenous |