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Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT00334074
First received: June 2, 2006
Last updated: July 15, 2013
Last verified: July 2013
Results First Received: April 1, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Myelogenous Leukemia
Myelodysplastic Syndromes
Chronic Myelogenous Leukemia
Intervention: Drug: Clofarabine and Cytarabine

  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
Patients were recruited after the initial IRB approval in september 2004 at Baylor University Medical Center. Enrollment was closed in october 2006. The study was completed Including follow up in February 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Clofarabine and Cytarabine 5 consecutive days of Clofarabine 40 mg/m^2 intravenous infusion over 1 hour followed 4 hours later by cytarabine 1000mg/m^2 intravenous infusion over 2 hours.Next cycle will start approximately 4 weeks after Day 1 of previous cycle. Patients will receive a maximum of 4 cycles of study treatment.

Participant Flow:   Overall Study
    Clofarabine and Cytarabine
STARTED   30 
COMPLETED   30 
NOT COMPLETED   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.
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Reporting Groups
  Description
Clofarabine and Cytarabine Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.

Baseline Measures
   Clofarabine and Cytarabine 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 64  (21) 
Gender 
[Units: Participants]
 
Female   13 
Male   17 
Region of Enrollment 
[Units: Participants]
 
United States   30 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Rate (Complete Response [CR] Plus Partial Response [PR]) of Clofarabine Plus Cytarabine in Patients With Relapsed/Refractory AML, Untreated MDS, CML in Blast Phase, or in Selected Untreated Patients With High Risk of Anthracycline Toxicity   [ Time Frame: Proportion of confirmed responses was estimated by the number of patients who achieved a CR or PR, defined as two consecutive evaluations at least 4 weeks apart, divided by the number of eligible participants in the study. ]

2.  Secondary:   Number of Participants Who Had an Adverse Event While on Treatment With Clofarabine Plus Cytarabine   [ Time Frame: Up to five months (includes follow up period of 30 days) from the day patient received their first dose of study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Edward Agura
Organization: Baylor University Medical Center
phone: 214-818-8472
e-mail: Sandyli@baylorhealth.edu



Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00334074     History of Changes
Other Study ID Numbers: 004-145
004-145 ( Other Identifier: Baylor Internal Review Board )
Study First Received: June 2, 2006
Results First Received: April 1, 2013
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration