Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00472849
First received: May 11, 2007
Last updated: November 1, 2013
Last verified: November 2013
Results First Received: August 9, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Richter's Transformation
Leukemia
Interventions: Drug: Oxaliplatin
Drug: Fludarabine
Drug: Cytarabine
Drug: Rituximab
Drug: Pegfilgrastim

  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 5/31/2007- 2/1/2012; All participants were 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
Of the 92 participants enrolled on this study, two participants were excluded as having failed screening and never received study medication.

Reporting Groups
  Description
OFAR (Phase I) Oxaliplatin starting dose 30 mg/m^2/day over 2 hours on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily intravenous (IV) over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
OFAR (Phase II) Oxaliplatin 25 mg/m^2 IV per day (Phase I MTD) on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.

Participant Flow:   Overall Study
    OFAR (Phase I)     OFAR (Phase II)  
STARTED     12     78  
COMPLETED     12     78  
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.
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Reporting Groups
  Description
OFAR (Phase I) Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
OFAR MTD (Phase II) Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
Total Total of all reporting groups

Baseline Measures
    OFAR (Phase I)     OFAR MTD (Phase II)     Total  
Number of Participants  
[units: participants]
  12     78     90  
Age  
[units: Years]
Median ( Full Range )
  65  
  ( 46 to 76 )  
  63  
  ( 40 to 81 )  
  63  
  ( 40 to 81 )  
Gender  
[units: participants]
     
Female     3     20     23  
Male     9     58     67  
Region of Enrollment  
[units: participants]
     
United States     12     78     90  



  Outcome Measures
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1.  Primary:   Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days)   [ Time Frame: Up to 36 weeks (6 cycles each 4-6 weeks) ]

2.  Secondary:   Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission   [ Time Frame: Up to 36 weeks (6 cycles each 4-6 weeks) ]


  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 G. Wierda, MD, PhD, BS / Associate Professor
Organization: The University of Texas MD 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: NCT00472849     History of Changes
Other Study ID Numbers: 2006-1026
Study First Received: May 11, 2007
Results First Received: August 9, 2013
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board