Trial Outcomes & Findings for A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I) (NCT NCT00317642)

Last Updated: 2014-04-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

326 participants

Primary outcome timeframe

Day 1 (randomization) up to approximately 4 years

Results posted on

2014-04-14

Participant Flow

352 patients screened and 326 randomized, 163 to each treatment group. One participant withdrew after being randomized to the Placebo and Cytarabine Group and was excluded from efficacy analysis.

Participant milestones

Participant milestones
Measure	Clofarabine (IV Formulation) and Cytarabine Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Overall Study STARTED	163	163
Overall Study Full Analysis Set	162	158
Overall Study Received >= 1 Study Drug (Safety Set)	161	155
Overall Study COMPLETED	41	28
Overall Study NOT COMPLETED	122	135

Reasons for withdrawal

Reasons for withdrawal
Measure	Clofarabine (IV Formulation) and Cytarabine Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Overall Study Not Received Either Study Drug	1	3
Overall Study Physician Decision	15	7
Overall Study Participant declined treatment	14	3
Overall Study Adverse Event	17	5
Overall Study Treatment Failure	56	102
Overall Study Disease Recurrence	1	2
Overall Study Death	14	7
Overall Study Not Continue to Consolidation	2	0
Overall Study Withdrawal by Subject	0	1
Overall Study Referred For Transplantation	1	0
Overall Study AML Not Centrally Confirmed	1	5

Baseline Characteristics

A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clofarabine (IV Formulation) and Cytarabine n=162 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine n=158 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Total n=320 Participants Total of all reporting groups
Age, Continuous	67.0 years STANDARD_DEVIATION 6.36 • n=5 Participants	67.1 years STANDARD_DEVIATION 5.82 • n=7 Participants	67.0 years STANDARD_DEVIATION 6.09 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	57 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	101 Participants n=7 Participants	215 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	153 Participants n=5 Participants	152 Participants n=7 Participants	305 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	150 Participants n=5 Participants	142 Participants n=7 Participants	292 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Height (cm)	171.5 centimeter STANDARD_DEVIATION 10.27 • n=5 Participants	170.5 centimeter STANDARD_DEVIATION 8.92 • n=7 Participants	171.0 centimeter STANDARD_DEVIATION 9.62 • n=5 Participants
Weight(kg)	81.21 kg STANDARD_DEVIATION 17.862 • n=5 Participants	83.03 kg STANDARD_DEVIATION 17.281 • n=7 Participants	82.11 kg STANDARD_DEVIATION 17.574 • n=5 Participants
Body Surface Area (BSA)	1.941 m^2 STANDARD_DEVIATION 0.2383 • n=5 Participants	1.959 m^2 STANDARD_DEVIATION 0.2338 • n=7 Participants	1.950 m^2 STANDARD_DEVIATION 0.2359 • n=5 Participants
Eastern Cooperative Oncology Group Performance Status ECOG 0	57 Participants n=5 Participants	48 Participants n=7 Participants	105 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status ECOG 1	79 Participants n=5 Participants	92 Participants n=7 Participants	171 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status ECOG 2	26 Participants n=5 Participants	18 Participants n=7 Participants	44 Participants n=5 Participants
Karyotype Favorable	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Karyotype Intermediate	65 participants n=5 Participants	84 participants n=7 Participants	149 participants n=5 Participants
Karyotype Unfavorable	86 participants n=5 Participants	70 participants n=7 Participants	156 participants n=5 Participants
Karyotype Not Assessed	8 participants n=5 Participants	3 participants n=7 Participants	11 participants n=5 Participants
Karyotype unknown	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (randomization) up to approximately 4 years

Population: Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.

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.

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=162 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=157 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months n=88 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months n=83 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months n=74 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months n=74 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Overall Survival - Overall and by Calculated Strata (CSR 7-April-11)	6.6 months Interval 5.1 to 9.3	6.4 months Interval 4.7 to 7.3	5.1 months Interval 3.5 to 8.7	5.5 months Interval 4.1 to 7.2	8.7 months Interval 5.3 to 11.1	7.2 months Interval 4.6 to 8.9

PRIMARY outcome

Timeframe: Day 1 (randomization) up to approximately 4 years

Population: Full Analysis Set (FAS) - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.

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.

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=162 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=158 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months n=86 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months n=84 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months n=76 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months n=74 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Overall Survival - Overall and by Randomized Strata (CSR 9-July-12)	6.6 months Interval 5.1 to 9.3	6.3 months Interval 4.7 to 7.3	4.8 months Interval 2.9 to 7.3	6.3 months Interval 4.1 to 7.8	9.7 months Interval 5.9 to 12.7	6.6 months Interval 4.3 to 8.8

SECONDARY outcome

Timeframe: Day 12 up to approximately 6 months

Percentage of participants whose best response was assessed by the IRRP as complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) using the revised International Working Group for Response Criteria (Cheson 2003). CR is defined on morphologic criteria at a single response assessment: * a bone marrow aspirate or biopsy of \<5% blasts, with evidence of normal hematopoiesis; * absence of Auer rods in the blasts that are present; * absence of extramedullary disease; * absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; * only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow; * recovery of peripheral counts (platelets ≥100\*10\^9/L and absolute neutrophil count (ANC) ≥1.0\*10\^9/L). CRi met all criteria for CR except for either residual neutropenia (ANC \<1.0\*10\^9/L) or thrombocytopenia (platelet count \<100\*10\^9/L).

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=162 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=157 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months n=88 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months n=83 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months n=74 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months n=74 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Best Response Per Independent Response Review Panel (IRRP) Assessment - Overall and by Calculated Strata (CSR 7-April-11) Overall Remission (CR + CRi)	46.9 percentage of participants	22.9 percentage of participants	45.5 percentage of participants	22.9 percentage of participants	48.6 percentage of participants	23.0 percentage of participants
Best Response Per Independent Response Review Panel (IRRP) Assessment - Overall and by Calculated Strata (CSR 7-April-11) Complete Remission (CR)	35.2 percentage of participants	17.8 percentage of participants	33.0 percentage of participants	18.1 percentage of participants	37.8 percentage of participants	17.6 percentage of participants
Best Response Per Independent Response Review Panel (IRRP) Assessment - Overall and by Calculated Strata (CSR 7-April-11) CR with incomplete blood count recovery (CRi)	11.7 percentage of participants	5.1 percentage of participants	12.5 percentage of participants	4.8 percentage of participants	10.8 percentage of participants	5.4 percentage of participants

SECONDARY outcome

Timeframe: Day 12 to approximately 4 years

Population: Participants in the FAS who achieved OR (CR + CRi). Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes.

DOR was defined as the time from first CR or CRi to the date of first objective documentation of disease recurrence, initiation of alternative antileukemic therapy \[including hematopoietic stem cell transplant\] while in remission, or death due to any cause, whichever occurred first. CR is defined on morphologic criteria at a single response assessment: * a bone marrow aspirate or biopsy of \<5% blasts, with evidence of normal hematopoiesis; * absence of Auer rods in the blasts that are present; * absence of extramedullary disease; * absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; * only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow; * recovery of peripheral counts (platelets ≥100\*10\^9/L and absolute neutrophil count (ANC) ≥1.0\*10\^9/L). CRi met all criteria for CR except for either residual neutropenia (ANC \<1.0\*10\^9/L) or thrombocytopenia (platelet count \<100\*10\^9/L).

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=76 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=36 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months n=40 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months n=19 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months n=36 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months n=17 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Duration of Remission (DOR) Per IRRP Assessment-Overall and by Calculated Strata (CSR 7-April-11)	7.6 months Interval 5.4 to 11.5	3.8 months Interval 3.3 to 12.1	5.7 months Interval 5.3 to 7.7	6.3 months Interval 2.3 to 7.2	11.5 months Interval 6.8 to 15.5	3.8 months Interval 3.3 to N/A = There were an insufficient number of events to allow estimation of the upper limit.

SECONDARY outcome

Timeframe: Day 12 to approximately 4 years

Population: Participants in the FAS who achieved OR (CR + CRi). Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=76 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=36 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months n=36 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months n=20 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months n=40 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months n=16 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Duration of Remission (DOR) Per IRRP Assessment-Overall and by Randomized Strata (CSR 9-July-12)	7.7 months Interval 5.7 to 11.5	3.8 months Interval 3.3 to 12.1	6.7 months Interval 4.0 to 8.8	6.3 months Interval 2.3 to 7.2	10.2 months Interval 6.8 to 20.2	3.8 months Interval 3.3 to There were an insufficient number of events to allow estimation of the upper limit.

SECONDARY outcome

Timeframe: Day 12 to approximately 4 years

Disease-free survival was defined as the time from first complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) until the date of first objective documentation of disease recurrence or death due to any cause, whichever occurred first. See Outcome #3 for definition of CR and CRi. Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease.

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=76 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=36 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months n=40 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months n=19 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months n=36 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months n=17 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Disease-free Survival by IRRP Assessment - Overall and by Calculated Strata (CSR 7-April-11)	8.1 months Interval 6.7 to 10.3	7.0 months Interval 3.9 to 12.1	5.7 months Interval 4.4 to 9.7	6.7 months Interval 3.9 to 8.1	10.3 months Interval 7.5 to 15.5	9.1 months Interval 3.7 to NA = There were an insufficient number of events to allow estimation of the upper limit.

SECONDARY outcome

Timeframe: Day 12 to approximately 4 years

Population: Participants in the FAS who achieved OR (CR + CRi). Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=76 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=36 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months n=36 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months n=20 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months n=40 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months n=16 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Disease-free Survival by IRRP Assessment - Overall and by Randomized Strata (CSR 9-July-12)	9.5 months Interval 6.9 to 15.4	7.0 months Interval 3.9 to 9.8	6.7 months Interval 3.9 to 9.7	6.7 months Interval 3.9 to 8.1	15.4 months Interval 9.2 to 20.5	9.2 months Interval 3.7 to 13.1

SECONDARY outcome

Timeframe: Day 1 (randomization) up to approximately 4 years

Event-free survival (EFS) was defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first. Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, \<30% decrease in % leukemic blasts). Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease.

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=162 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=157 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months n=88 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months n=83 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months n=74 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months n=74 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Event-free Survival by IRRP Assessment - Overall and by Calculated Strata (CSR 7-April-11)	1.9 months Interval 1.1 to 2.9	1.0 months Interval 0.9 to 1.1	1.4 months Interval 1.0 to 2.9	1.0 months Interval 0.7 to 1.2	2.0 months Interval 1.2 to 6.6	1.0 months Interval 0.9 to 1.2

SECONDARY outcome

Timeframe: Day 1 (randomization) up to approximately 4 years

Population: Full Analysis Set - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=162 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=158 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months n=86 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months n=84 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months n=76 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months n=74 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Event-free Survival by IRRP Assessment - Overall and by Randomized Strata (CSR 9-July-12)	1.9 months Interval 1.1 to 2.9	1.0 months Interval 0.8 to 1.1	1.1 months Interval 0.8 to 2.5	1.0 months Interval 0.7 to 1.2	2.8 months Interval 1.2 to 8.1	1.0 months Interval 0.8 to 1.2

SECONDARY outcome

Timeframe: Day 1 (randomization) to Day 122

Four-month event-free survival (EFS) was defined as achieving an EFS of at least 122 days, where EFS is defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first. Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, \<30% decrease in % leukemic blasts). Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease.

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=162 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=157 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months n=88 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months n=83 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months n=74 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months n=74 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Four-Month Event-free Survival Per IRRP Assessment - Overall and by Calculated Strata (CSR 7-April-11)	37.7 percentage of participants	16.6 percentage of participants	35.2 percentage of participants	16.9 percentage of participants	40.5 percentage of participants	16.2 percentage of participants

SECONDARY outcome

Timeframe: Day 1 (randomization) to Day 122

Population: Full Analysis Set - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, that is the strata include the IVRS mistakes.

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=162 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=158 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months n=86 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months n=84 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months n=76 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months n=74 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Four-Month Event-free Survival Per IRRP Assessment - Overall and by Randomized Strata (CSR 9-July-12)	38.9 percentage of participants	17.1 percentage of participants	31.4 percentage of participants	17.9 percentage of participants	47.4 percentage of participants	16.2 percentage of participants

SECONDARY outcome

Timeframe: Day 1 up to a maximum of 4 years (includes up to a maximum of 3 cycles of therapy plus 45 days follow up. Related AEs are followed to resolution.)

Population: Safety Set - Participants in the Full Analysis Set (FAS) who received at least 1 dose of study drug.

Number of participants with treatment emergent adverse events (TEAEs) or death due to related AE. Related AEs for the combination arm can be related to either clofarabine or cytarabine. Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life Threatening AE, Grade 5 = Death

Outcome measures

Outcome measures
Measure	Clofarabine (IV Formulation) and Cytarabine (FAS) n=161 Participants Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine (FAS) n=155 Participants Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine - In Stratum < 6 Months Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine - In Stratum < 6 Months Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.	Clofarabine and Cytarabine In Stratum >= 6 Months Participants received clofarabine 40 mg/m\^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.	Placebo and Cytarabine In Stratum >= 6 Months Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m\^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
Participants With Adverse Events (CSR 7-April-11) Any Treatment Emergent AE	161 participants	155 participants	—	—	—	—
Participants With Adverse Events (CSR 7-April-11) Any Related Treatment Emergent AE	157 participants	133 participants	—	—	—	—
Participants With Adverse Events (CSR 7-April-11) Any Treatment Emergent Grade >=3 AE	157 participants	133 participants	—	—	—	—
Participants With Adverse Events (CSR 7-April-11) Any Related Treatment Related Grade >=3 AE	127 participants	83 participants	—	—	—	—
Participants With Adverse Events (CSR 7-April-11) Discontinue of study medication due to AE	17 participants	5 participants	—	—	—	—
Participants With Adverse Events (CSR 7-April-11) Discontinue of study medication due to related AE	14 participants	3 participants	—	—	—	—

Adverse Events

Clofarabine (IV Formulation) and Cytarabine

Serious events: 97 serious events

Other events: 161 other events

Deaths: 0 deaths

Placebo and Cytarabine

Serious events: 76 serious events

Other events: 154 other events

Deaths: 0 deaths

Overall

Serious events: 173 serious events

Other events: 315 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

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