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Oral Clofarabine Study in Patients With Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00299156
Recruitment Status : Completed
First Posted : March 6, 2006
Results First Posted : September 18, 2015
Last Update Posted : November 3, 2015
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
Conditions: Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Intervention: Drug: Clofarabine

  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: March 2006 to July 2012. All patients 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
Sixty-five participants were registered, one participant did not receive study treatment. The study consisted of two parts, Phase 1 and a randomized Phase 2 portion.

Reporting Groups
  Description
Oral Clofarabine Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
Randomized, Oral Clofarabine 10mg Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
Randomized, Oral Clofarabine 20mg Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.

Participant Flow for 2 periods

Period 1:   Period 1 (Non-Randomized)
    Oral Clofarabine   Randomized, Oral Clofarabine 10mg   Randomized, Oral Clofarabine 20mg
STARTED   32   0   0 
COMPLETED   32   0   0 
NOT COMPLETED   0   0   0 

Period 2:   Period 2 (Randomized)
    Oral Clofarabine   Randomized, Oral Clofarabine 10mg   Randomized, Oral Clofarabine 20mg
STARTED   0   17   16 
COMPLETED   0   16   16 
NOT COMPLETED   0   1   0 
Screen Failure                0                1                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
Oral Clofarabine Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
Randomized, Oral Clofarabine 10mg Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
Randomized, Oral Clofarabine 20mg Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
Total Total of all reporting groups

Baseline Measures
   Oral Clofarabine   Randomized, Oral Clofarabine 10mg   Randomized, Oral Clofarabine 20mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   17   16   65 
Age 
[Units: Years]
Median (Full Range)
 70.0 
 (53 to 86) 
 67.5 
 (43 to 87) 
 72.5 
 (54 to 84) 
 70.0 
 (43 to 87) 
Gender 
[Units: Participants]
       
Female   9   7   7   23 
Male   23   10   9   42 
Region of Enrollment 
[Units: Participants]
       
United States   32   17   16   65 


  Outcome Measures

1.  Primary:   Participants With a Complete Remission (CR)   [ Time Frame: After 3 courses of treatment, up to 24 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: Hagop Kantarjian, MD /Professor
Organization: The University of Texas MD Anderson Cancer Center
phone: 713-792-7026
e-mail: eharrison@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00299156     History of Changes
Other Study ID Numbers: 2005-0536
First Submitted: March 3, 2006
First Posted: March 6, 2006
Results First Submitted: August 19, 2015
Results First Posted: September 18, 2015
Last Update Posted: November 3, 2015