Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Richter's Syndrome, Refractory CLL and PLL

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00452374
First received: March 23, 2007
Last updated: October 25, 2011
Last verified: October 2011
Results First Received: July 28, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: Cytarabine
Drug: Fludarabine
Drug: Oxaliplatin
Drug: Rituximab

  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: 11/15/04 to 4/24/07. All patients registered at the University of Texas MD 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
Oxaliplatin, Fludarabine, Cytarabine + Rituximab Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.

Participant Flow:   Overall Study
    Oxaliplatin, Fludarabine, Cytarabine + Rituximab  
STARTED     48  
COMPLETED     48  
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.
No text entered.

Reporting Groups
  Description
Oxaliplatin, Fludarabine, Cytarabine + Rituximab Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.

Baseline Measures
    Oxaliplatin, Fludarabine, Cytarabine + Rituximab  
Number of Participants  
[units: participants]
  48  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 37 to 78 )  
Gender  
[units: participants]
 
Female     14  
Male     34  
Region of Enrollment  
[units: participants]
 
United States     48  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD) Oxaliplatin   [ Time Frame: From treatment onset to end of each cycle of treatment (every 21 days) ]

2.  Secondary:   Number of Participants With a Complete Response or Partial Response   [ Time Frame: Evaluation every 3 cycles of treatment (28 days per cycle), approximately 90 days ]


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


Results Point of Contact:  
Name/Title: William Wierda, M.D./Associate Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713-745-0428
e-mail: eharriso@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00452374     History of Changes
Other Study ID Numbers: 2004-0373
Study First Received: March 23, 2007
Results First Received: July 28, 2011
Last Updated: October 25, 2011
Health Authority: United States: Food and Drug Administration