Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS).

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00088218
First received: July 22, 2004
Last updated: August 1, 2012
Last verified: April 2011
Results First Received: September 25, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Interventions: Drug: Clofarabine
Drug: Ara-C

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period 7/21/04 - 2/15/08; all patients were registered at The University of Texas M.D. Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Clofarabine Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
Clofarabine Plus Ara-C Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.

Participant Flow:   Overall Study
    Clofarabine     Clofarabine Plus Ara-C  
STARTED     16     79  
COMPLETED     16     79  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Clofarabine Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
Clofarabine Plus Ara-C Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
Total Total of all reporting groups

Baseline Measures
    Clofarabine     Clofarabine Plus Ara-C     Total  
Number of Participants  
[units: participants]
  16     79     95  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     12     13  
>=65 years     15     67     82  
Age  
[units: years]
Median ( Full Range )
  72  
  ( 60 to 83 )  
  70  
  ( 60 to 82 )  
  70  
  ( 60 to 83 )  
Gender  
[units: participants]
     
Female     4     34     38  
Male     12     45     57  
Region of Enrollment  
[units: participants]
     
United States     16     79     95  



  Outcome Measures

1.  Primary:   Number of Participants With Response   [ Time Frame: Every 2 to 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Stefan Fader, M.D./Associate Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713/745-4613
e-mail: eharriso@mdanderson.org


No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00088218     History of Changes
Other Study ID Numbers: 2004-0183
Study First Received: July 22, 2004
Results First Received: September 25, 2009
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration