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Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction

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ClinicalTrials.gov Identifier: NCT01025154
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : October 30, 2013
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Myeloid Leukemia
Interventions Drug: Clofarabine
Drug: Idarubicin
Drug: Cytarabine
Enrollment 63
Recruitment Details Recruitment Period 1/28/2010 - 2/20/2013; All participants were registered at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details Of the 63 participants registered, four (4) were excluded prior to study starting.
Arm/Group Title Clofarabine, Cytarabine + Idarubicin
Hide Arm/Group Description 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
Period Title: Overall Study
Started 59
Completed 57
Not Completed 2
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             1
Arm/Group Title Clofarabine, Cytarabine + Idarubicin
Hide Arm/Group Description 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 Number of Baseline Participants 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 59 participants
48
(19 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
32
  54.2%
Male
27
  45.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants
59
1.Primary Outcome
Title Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery
Hide Description 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.
Time Frame 8 weeks after Induction therapy (induction cycle 4-6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Two of the fifty-nine participants were not evaluable.
Arm/Group Title Clofarabine, Cytarabine + Idarubicin
Hide Arm/Group Description:
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 Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
Complete Remission 42
Complete Remission without Platelet Recovery 3
2.Primary Outcome
Title Median Event-Free Survival (EFS)
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Two of the fifty-nine participants were not included in the analysis.
Arm/Group Title Clofarabine, Cytarabine + Idarubicin
Hide Arm/Group Description:
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 Number of Participants Analyzed 57
Median (Full Range)
Unit of Measure: Months
13.5
(1 to 23)
Time Frame 1 Year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clofarabine, Cytarabine + Idarubicin
Hide Arm/Group Description 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
All-Cause Mortality
Clofarabine, Cytarabine + Idarubicin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clofarabine, Cytarabine + Idarubicin
Affected / at Risk (%) # Events
Total   36/59 (61.02%)    
Cardiac disorders   
Atrial Fibrillation  1  1/59 (1.69%)  1
General disorders   
Pain  1  2/59 (3.39%)  3
Headache  1  1/59 (1.69%)  1
Infections and infestations   
Febrile Neutropenia  1  19/59 (32.20%)  30
Infection  1  17/59 (28.81%)  24
Nervous system disorders   
Seizure  1  1/59 (1.69%)  1
Somnolence  1  1/59 (1.69%)  1
Renal and urinary disorders   
Renal Failure  1  1/59 (1.69%)  1
Skin and subcutaneous tissue disorders   
Erythema Multiforme  1  1/59 (1.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clofarabine, Cytarabine + Idarubicin
Affected / at Risk (%) # Events
Total   56/59 (94.92%)    
Gastrointestinal disorders   
Constipation  1  5/59 (8.47%)  5
Diarrhea  1  14/59 (23.73%)  14
Mucositis/stomatitis  1  6/59 (10.17%)  6
Nausea  1  24/59 (40.68%)  25
Vomiting  1  3/59 (5.08%)  3
Pain  1  14/59 (23.73%)  14
Infections and infestations   
Febrile Neutropenia/fever of unknown origin  1  14/59 (23.73%)  16
Infection  1  7/59 (11.86%)  7
Metabolism and nutrition disorders   
Elevated ALT/AST  1  11/59 (18.64%)  11
Hyperbilirubinemia  1  9/59 (15.25%)  9
Hyperkalemia  1  6/59 (10.17%)  6
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  19/59 (32.20%)  20
Rash/hand-foot skin reaction  1  4/59 (6.78%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Stefan Faderl, MD / Associate Professor
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-745-4613
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01025154     History of Changes
Other Study ID Numbers: 2009-0431
First Submitted: December 1, 2009
First Posted: December 3, 2009
Results First Submitted: August 19, 2013
Results First Posted: October 30, 2013
Last Update Posted: October 9, 2018