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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).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00088218
Recruitment Status : Completed
First Posted : July 23, 2004
Results First Posted : May 9, 2011
Last Update Posted : August 7, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Interventions: Drug: Clofarabine
Drug: Ara-C

  Participant Flow

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

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 
Overall Participants Analyzed 
[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


  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.


  More Information

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


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00088218     History of Changes
Other Study ID Numbers: 2004-0183
First Submitted: July 22, 2004
First Posted: July 23, 2004
Results First Submitted: September 25, 2009
Results First Posted: May 9, 2011
Last Update Posted: August 7, 2012