Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00317642 | A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I) | PHASE3 | COMPLETED | 326 | — | — | Aug 1, 2006 | Jan 1, 2012 | Apr 14, 2014 | 57 | United States, Canada +3 |
| NCT00373529 | A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II) | PHASE2 | COMPLETED | 116 | — | — | Oct 1, 2006 | May 1, 2010 | Apr 14, 2014 | 20 | United States |
| NCT00044889 | Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia | PHASE2 | COMPLETED | 40 | — | — | May 1, 2002 | Mar 1, 2003 | Mar 19, 2014 | 12 | United States |
| NCT01090167 | A Study of Clofarabine in Japanese Patients With Acute Myeloid Leukemia (AML) | PHASE1 | COMPLETED | 14 | — | — | Feb 1, 2010 | Apr 1, 2011 | Mar 19, 2014 | 6 | Japan |
Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 calculated strata. OS was defined as the number of months from date of randomization until date of death due to any cause.
Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 randomized strata. OS was defined as the number of months from date of randomization until date of death due to any cause.
Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment. Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp). CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease. Partial remission(PR) includes recovery of peripheral blood cells with improved but still abnormal values in leukemic blast cells.
| Arm | Type | Description |
|---|---|---|
| clofarabine (IV formulation) and cytarabine | EXPERIMENTAL | Participants received clofarabine (40 mg/m\^2) administered as a 1-hour infusion followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour infusion. Participants could receive up to 3 cycles of treatment (induction, re-induction, and consolidation) Complete induction cycle = 5 consecutive days of treatment Re-induction cycle = 5 consecutive days of treatment at the original or modified dose Consolidation cycle = 4 consecutive days of treatment at the original or modified dose |
| placebo and cytarabine | EXPERIMENTAL | Participants received placebo administered as a 1-hour infusion followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour infusion. Patients could receive up to 3 cycles of treatment (induction, re-induction, and consolidation) |
| Clofarabine | EXPERIMENTAL | Participants received an induction cycle of clofarabine 30 mg/m\^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m\^2/day intravenous infusion for 5 consecutive days. |
| Name | Type | Description |
|---|---|---|
| clofarabine (IV formulation) | DRUG | clofarabine (IV formulation) infusion 40mg/m\^2 / day up to 3 cycles |
| placebo | DRUG | placebo (sodium Chloride) 1-hour IV infusion |
| cytarabine | DRUG | cytarabine IV infusion 1g/m\^2/day for up to 3 cycles |
| clofarabine | DRUG | Induction cycle 1: cycle 1 of clofarabine 30 mg/m\^2/day as a 1-hour intravenous infusion for 5 consecutive days. Reinduction (cycle 2) and/or Consolidation cycles (cycles 2-6): cycles repeated minimally every 28 days, of clofarabine 20 mg/m\^2/day as a 1-hour intravenous infusion for 5 consecutive days. |
Inclusion Criteria: * Have a diagnosis of Acute Myelogenous Leukemia (AML) according to World Health Organization (WHO) classification * Relapsed after receiving up to 2 prior induction regimens (i.e. first or second relapse)or are refractory to not more than one prior combination chemotherapy indu...