Trial Outcomes & Findings for Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (NCT NCT01289457)
NCT ID: NCT01289457
Last Updated: 2020-02-24
Results Overview
MTD is highest dose level in which \<2 patients of 6 develop first cycle dose limiting toxicities (DLT). Toxicity defined as any treatment-related grade 3 or greater non-hematological toxicities.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
282 participants
Primary outcome timeframe
28 days
Results posted on
2020-02-24
Participant Flow
Participant milestones
| Measure |
Clofarabine + Idarubicin + Cytarabine
Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 1 CIA
Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 2 FLAI
Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5).
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
157
|
113
|
|
Overall Study
COMPLETED
|
12
|
157
|
113
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome
Baseline characteristics by cohort
| Measure |
Clofarabine + Idarubicin + Cytarabine
n=12 Participants
Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 1 CIA
n=157 Participants
Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 2 FLAI
n=113 Participants
Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5).
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Continuous
|
52 years
n=5 Participants
|
53 years
n=7 Participants
|
51 years
n=5 Participants
|
53 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
157 participants
n=7 Participants
|
113 participants
n=5 Participants
|
282 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Maximum Tolerated Dose (MTD) is only reported for the Phase I portion of the study. MTD was not done on the Phase II portion of the study and therefore, PhII Groups 1 and 2 do not have results for MTD.
MTD is highest dose level in which \<2 patients of 6 develop first cycle dose limiting toxicities (DLT). Toxicity defined as any treatment-related grade 3 or greater non-hematological toxicities.
Outcome measures
| Measure |
Clofarabine + Idarubicin + Cytarabine
n=12 Participants
Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 1 CIA
Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 2 FLAI
Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5).
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Clofarabine, Idarubicin, and Cytarabine
|
15 mg/m^2
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The outcome measure for for the Phase I portion of this study was to determine MTD only. Data Was not collected for Response Rate for the Phase I arm of this study.
NCI \& Myelodysplastic syndromes (MDS) International Working Group (IWG) Definitions: Complete Response (CR): Neutrophil count ≥1.0 ×10\^9/L, Platelet count ≥100 ×10\^9/L, Bone marrow aspirate \</=5% blasts, No extramedullary leukemia; CRi: Response as in CR but platelets \<100 ×10\^9/L; Partial response (PR): Neutrophil count ≥ 1.0 ×10\^9/L, Platelet count ≥100 ×10\^9/L, ≥ 50% reduction in bone marrow blasts over baseline; Clinical benefit: In addition to IWG criteria, in AML, a decrease in bone marrow blasts to \<5% is also considered clinical benefit; Stable Disease: In addition to IWG criteria and in absence any of above response criteria, stable disease considered if the bone marrow blast percent does not increase compared to pretreatment level; Relapse: Increase of bone marrow blasts to \>10% after initial response. Response assessed Day 28 of every 2-3 cycles during treatment.
Outcome measures
| Measure |
Clofarabine + Idarubicin + Cytarabine
Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 1 CIA
n=157 Participants
Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 2 FLAI
n=113 Participants
Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5).
|
|---|---|---|---|
|
Response Rates of Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI)
|
—
|
107 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years or until relapse/deathPopulation: The outcome measure for for the Phase I portion of this study was to determine MTD only. Data Was not collected for EFS for the Phase I arm of this study.
Comparison of the event-free survival (EFS) between treatment CIA and FLAI, where an event is defined to be resistance to treatment, relapse (after response) or death, whichever occurred first.
Outcome measures
| Measure |
Clofarabine + Idarubicin + Cytarabine
Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 1 CIA
n=157 Participants
Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 2 FLAI
n=113 Participants
Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5).
|
|---|---|---|---|
|
Event-Free Survival (EFS) at 2 Years
|
—
|
7.1 Months
Interval 1.0 to 69.0
|
8.4 Months
Interval 1.0 to 69.0
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: The outcome measure for the Phase I portion of this study was to determine MTD only. Data Was not collected for Overall Survival for the Phase I arm of this study.
Time from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Clofarabine + Idarubicin + Cytarabine
Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 1 CIA
n=157 Participants
Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 2 FLAI
n=113 Participants
Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5).
|
|---|---|---|---|
|
Overall Survival
|
—
|
14.5 Months
Interval 1.0 to 70.0
|
15.1 Months
Interval 1.0 to 70.0
|
Adverse Events
Clofarabine + Idarubicin + Cytarabine
Serious events: 10 serious events
Other events: 12 other events
Deaths: 4 deaths
Group 1 CIA
Serious events: 126 serious events
Other events: 150 other events
Deaths: 8 deaths
Group 2 FLAI
Serious events: 89 serious events
Other events: 109 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Clofarabine + Idarubicin + Cytarabine
n=12 participants at risk
Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 1 CIA
n=157 participants at risk
Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 2 FLAI
n=113 participants at risk
Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5).
|
|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Gastrointestinal disorders
Allergic Reaction
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Nervous system disorders
Altered Mental Status
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Nervous system disorders
Bell's Palsy
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Eye disorders
Blurred Vision
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Cardiac disorders
Cardiac Arrhythmia
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Gastrointestinal disorders
Cholecystitis
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
1.8%
2/113 • Number of events 2 • up to 1 year
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
General disorders
Death
|
33.3%
4/12 • Number of events 4 • up to 1 year
|
3.2%
5/157 • Number of events 5 • up to 1 year
|
1.8%
2/113 • Number of events 2 • up to 1 year
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/12 • up to 1 year
|
1.9%
3/157 • Number of events 3 • up to 1 year
|
2.7%
3/113 • Number of events 3 • up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • up to 1 year
|
1.3%
2/157 • Number of events 2 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Blood and lymphatic system disorders
Disseminated Intravastular Coagulation
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Surgical and medical procedures
Drain Placement
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Metabolism and nutrition disorders
Elevated Alanine Aminotransferase
|
0.00%
0/12 • up to 1 year
|
2.5%
4/157 • Number of events 4 • up to 1 year
|
1.8%
2/113 • Number of events 2 • up to 1 year
|
|
Metabolism and nutrition disorders
Elevated Amylase
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Metabolism and nutrition disorders
Elevated Amylase/Lipase
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 2 • up to 1 year
|
|
Metabolism and nutrition disorders
Elevated Lipase
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
General disorders
Fever
|
0.00%
0/12 • up to 1 year
|
2.5%
4/157 • Number of events 4 • up to 1 year
|
2.7%
3/113 • Number of events 3 • up to 1 year
|
|
Skin and subcutaneous tissue disorders
Hand Foot Syndrome
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/12 • up to 1 year
|
3.8%
6/157 • Number of events 7 • up to 1 year
|
7.1%
8/113 • Number of events 8 • up to 1 year
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Cardiac disorders
Hypertension
|
0.00%
0/12 • up to 1 year
|
1.3%
2/157 • Number of events 2 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Cardiac disorders
Hypotension
|
0.00%
0/12 • up to 1 year
|
1.3%
2/157 • Number of events 2 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
General disorders
Infection
|
58.3%
7/12 • Number of events 9 • up to 1 year
|
33.1%
52/157 • Number of events 80 • up to 1 year
|
20.4%
23/113 • Number of events 26 • up to 1 year
|
|
Renal and urinary disorders
Kidney Stones
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Nervous system disorders
Mental Status
|
0.00%
0/12 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
3.2%
5/157 • Number of events 7 • up to 1 year
|
4.4%
5/113 • Number of events 7 • up to 1 year
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Infections and infestations
Neutropenic Fever
|
16.7%
2/12 • Number of events 2 • up to 1 year
|
47.8%
75/157 • Number of events 122 • up to 1 year
|
50.4%
57/113 • Number of events 88 • up to 1 year
|
|
General disorders
Pain
|
0.00%
0/12 • up to 1 year
|
7.6%
12/157 • Number of events 15 • up to 1 year
|
10.6%
12/113 • Number of events 16 • up to 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/12 • up to 1 year
|
1.3%
2/157 • Number of events 2 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • up to 1 year
|
1.3%
2/157 • Number of events 2 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/12 • up to 1 year
|
1.9%
3/157 • Number of events 3 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/12 • up to 1 year
|
1.9%
3/157 • Number of events 3 • up to 1 year
|
2.7%
3/113 • Number of events 3 • up to 1 year
|
|
Nervous system disorders
Seizure
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 2 • up to 1 year
|
1.8%
2/113 • Number of events 2 • up to 1 year
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/12 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
Other adverse events
| Measure |
Clofarabine + Idarubicin + Cytarabine
n=12 participants at risk
Phase I: Clofarabine Starting dose 15 mg/m2 by vein for 5 days (days 1-5) + Idarubicin 10 mg/m2 by vein on day 1-3 + Cytarabine 1 g/m2 by vein on day 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 1 CIA
n=157 participants at risk
Phase II, Group 1 CIA (Clofarabine + Idarubicin + Cytarabine): Clofarabine MTD based on Phase I by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Clofarabine: Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
|
Group 2 FLAI
n=113 participants at risk
Phase II, Group 2 FLAI (Fludarabine + Idarubicin + Cytarabine): Fludarabine 30 mg/m2 by vein on days 1-5; Idarubicin 10 mg/m2 by vein on days 1-3; Cytarabine 1 g/m2 by vein on days 1-5.
Idarubicin: 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
Cytarabine: 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
Fludarabine: 30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5).
|
|---|---|---|---|
|
Nervous system disorders
Tremor
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Skin Reaction
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
0.64%
1/157 • Number of events 1 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
3.5%
4/113 • Number of events 5 • up to 1 year
|
|
Nervous system disorders
Mental Status
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
1.9%
3/157 • Number of events 3 • up to 1 year
|
1.8%
2/113 • Number of events 2 • up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
1.9%
3/157 • Number of events 3 • up to 1 year
|
1.8%
2/113 • Number of events 2 • up to 1 year
|
|
Blood and lymphatic system disorders
Hemorrhage CNS
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
2.5%
4/157 • Number of events 4 • up to 1 year
|
1.8%
2/113 • Number of events 2 • up to 1 year
|
|
Nervous system disorders
CNS Cerebrovascular Ischemia
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
General disorders
Syndromes Other
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.00%
0/113 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
0.00%
0/157 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
5.7%
9/157 • Number of events 10 • up to 1 year
|
0.88%
1/113 • Number of events 1 • up to 1 year
|
|
Metabolism and nutrition disorders
Elevated Creatinine
|
0.00%
0/12 • up to 1 year
|
6.4%
10/157 • Number of events 10 • up to 1 year
|
2.7%
3/113 • Number of events 3 • up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • up to 1 year
|
5.7%
9/157 • Number of events 9 • up to 1 year
|
4.4%
5/113 • Number of events 5 • up to 1 year
|
|
Gastrointestinal disorders
Hemorrhage, Gastrointestinal
|
0.00%
0/12 • up to 1 year
|
2.5%
4/157 • Number of events 5 • up to 1 year
|
6.2%
7/113 • Number of events 9 • up to 1 year
|
|
Cardiac disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
5.1%
8/157 • Number of events 9 • up to 1 year
|
3.5%
4/113 • Number of events 4 • up to 1 year
|
|
Infections and infestations
Opportunistic Infection
|
0.00%
0/12 • up to 1 year
|
3.8%
6/157 • Number of events 7 • up to 1 year
|
6.2%
7/113 • Number of events 7 • up to 1 year
|
|
Metabolism and nutrition disorders
Elevated Aspartate Aminotransferase
|
16.7%
2/12 • Number of events 2 • up to 1 year
|
10.8%
17/157 • Number of events 17 • up to 1 year
|
3.5%
4/113 • Number of events 4 • up to 1 year
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/12 • up to 1 year
|
11.5%
18/157 • Number of events 18 • up to 1 year
|
11.5%
13/113 • Number of events 13 • up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • up to 1 year
|
14.6%
23/157 • Number of events 27 • up to 1 year
|
8.0%
9/113 • Number of events 11 • up to 1 year
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
0.00%
0/12 • up to 1 year
|
14.6%
23/157 • Number of events 24 • up to 1 year
|
10.6%
12/113 • Number of events 15 • up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
2/12 • Number of events 2 • up to 1 year
|
18.5%
29/157 • Number of events 29 • up to 1 year
|
17.7%
20/113 • Number of events 20 • up to 1 year
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
18.5%
29/157 • Number of events 30 • up to 1 year
|
18.6%
21/113 • Number of events 22 • up to 1 year
|
|
Metabolism and nutrition disorders
Elevated Alanine Aminotransferase
|
16.7%
2/12 • Number of events 2 • up to 1 year
|
25.5%
40/157 • Number of events 42 • up to 1 year
|
9.7%
11/113 • Number of events 11 • up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
58.3%
7/12 • Number of events 7 • up to 1 year
|
25.5%
40/157 • Number of events 42 • up to 1 year
|
9.7%
11/113 • Number of events 11 • up to 1 year
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
27.4%
43/157 • Number of events 47 • up to 1 year
|
12.4%
14/113 • Number of events 14 • up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • up to 1 year
|
26.8%
42/157 • Number of events 45 • up to 1 year
|
23.9%
27/113 • Number of events 29 • up to 1 year
|
|
General disorders
Pain
|
0.00%
0/12 • up to 1 year
|
27.4%
43/157 • Number of events 53 • up to 1 year
|
21.2%
24/113 • Number of events 29 • up to 1 year
|
|
Infections and infestations
Neutropenic Fever
|
66.7%
8/12 • Number of events 9 • up to 1 year
|
59.9%
94/157 • Number of events 140 • up to 1 year
|
42.5%
48/113 • Number of events 80 • up to 1 year
|
|
Infections and infestations
Infection
|
91.7%
11/12 • Number of events 29 • up to 1 year
|
44.6%
70/157 • Number of events 136 • up to 1 year
|
34.5%
39/113 • Number of events 66 • up to 1 year
|
Additional Information
Jabbour,Elias Joseph, M.D./Associate Professor
The University of Texas M D Anderson Cancer Center
Phone: 713-792-4764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place