Trial Outcomes & Findings for Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction (NCT NCT01025154)
NCT ID: NCT01025154
Last Updated: 2018-10-09
Results Overview
Overall Response (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L, and normal bone marrow differential (\< 5% blasts); and, Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of \< 100 x 10\^9/L. Response evaluated within 8 weeks after induction therapy.
COMPLETED
PHASE2
63 participants
8 weeks after Induction therapy (induction cycle 4-6 weeks)
2018-10-09
Participant Flow
Recruitment Period 1/28/2010 - 2/20/2013; All participants were registered at The University of Texas MD Anderson Cancer Center.
Of the 63 participants registered, four (4) were excluded prior to study starting.
Participant milestones
| Measure |
Clofarabine, Cytarabine + Idarubicin
Induction Cycle: Clofarabine 20 mg/m\^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m\^2 IV daily for 3 days; Cytarabine 1 g/m\^2 IV daily for 5 days
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Clofarabine, Cytarabine + Idarubicin
Induction Cycle: Clofarabine 20 mg/m\^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m\^2 IV daily for 3 days; Cytarabine 1 g/m\^2 IV daily for 5 days
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction
Baseline characteristics by cohort
| Measure |
Clofarabine, Cytarabine + Idarubicin
n=59 Participants
Induction Cycle: Clofarabine 20 mg/m\^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m\^2 IV daily for 3 days; Cytarabine 1 g/m\^2 IV daily for 5 days
|
|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after Induction therapy (induction cycle 4-6 weeks)Population: Two of the fifty-nine participants were not evaluable.
Overall Response (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L, and normal bone marrow differential (\< 5% blasts); and, Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of \< 100 x 10\^9/L. Response evaluated within 8 weeks after induction therapy.
Outcome measures
| Measure |
Clofarabine, Cytarabine + Idarubicin
n=57 Participants
Induction Cycle: Clofarabine 20 mg/m\^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m\^2 IV daily for 3 days; Cytarabine 1 g/m\^2 IV daily for 5 days
|
|---|---|
|
Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery
Complete Remission
|
42 participants
|
|
Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery
Complete Remission without Platelet Recovery
|
3 participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Two of the fifty-nine participants were not included in the analysis.
Event-free survival (EFS) defined as time from start of treatment to first documentation of disease relapse or death. Bayesian time-to-event model will be used to monitor progression free survival.
Outcome measures
| Measure |
Clofarabine, Cytarabine + Idarubicin
n=57 Participants
Induction Cycle: Clofarabine 20 mg/m\^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m\^2 IV daily for 3 days; Cytarabine 1 g/m\^2 IV daily for 5 days
|
|---|---|
|
Median Event-Free Survival (EFS)
|
13.5 Months
Interval 1.0 to 23.0
|
Adverse Events
Clofarabine, Cytarabine + Idarubicin
Serious adverse events
| Measure |
Clofarabine, Cytarabine + Idarubicin
n=59 participants at risk
Induction Cycle: Clofarabine 20 mg/m\^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m\^2 IV daily for 3 days; Cytarabine 1 g/m\^2 IV daily for 5 days
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
1.7%
1/59 • Number of events 1 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
1.7%
1/59 • Number of events 1 • 1 Year
|
|
Infections and infestations
Febrile Neutropenia
|
32.2%
19/59 • Number of events 30 • 1 Year
|
|
Infections and infestations
Infection
|
28.8%
17/59 • Number of events 24 • 1 Year
|
|
General disorders
Pain
|
3.4%
2/59 • Number of events 3 • 1 Year
|
|
Renal and urinary disorders
Renal Failure
|
1.7%
1/59 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Seizure
|
1.7%
1/59 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Somnolence
|
1.7%
1/59 • Number of events 1 • 1 Year
|
|
General disorders
Headache
|
1.7%
1/59 • Number of events 1 • 1 Year
|
Other adverse events
| Measure |
Clofarabine, Cytarabine + Idarubicin
n=59 participants at risk
Induction Cycle: Clofarabine 20 mg/m\^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m\^2 IV daily for 3 days; Cytarabine 1 g/m\^2 IV daily for 5 days
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
32.2%
19/59 • Number of events 20 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Rash/hand-foot skin reaction
|
6.8%
4/59 • Number of events 4 • 1 Year
|
|
Gastrointestinal disorders
Constipation
|
8.5%
5/59 • Number of events 5 • 1 Year
|
|
Gastrointestinal disorders
Diarrhea
|
23.7%
14/59 • Number of events 14 • 1 Year
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
10.2%
6/59 • Number of events 6 • 1 Year
|
|
Gastrointestinal disorders
Nausea
|
40.7%
24/59 • Number of events 25 • 1 Year
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
3/59 • Number of events 3 • 1 Year
|
|
Infections and infestations
Febrile Neutropenia/fever of unknown origin
|
23.7%
14/59 • Number of events 16 • 1 Year
|
|
Infections and infestations
Infection
|
11.9%
7/59 • Number of events 7 • 1 Year
|
|
Metabolism and nutrition disorders
Elevated ALT/AST
|
18.6%
11/59 • Number of events 11 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
15.3%
9/59 • Number of events 9 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.2%
6/59 • Number of events 6 • 1 Year
|
|
Gastrointestinal disorders
Pain
|
23.7%
14/59 • Number of events 14 • 1 Year
|
Additional Information
Stefan Faderl, MD / Associate Professor
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place