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Trial record 46 of 1990 for:    oxaliplatin

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

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ClinicalTrials.gov Identifier: NCT00452374
Recruitment Status : Completed
First Posted : March 27, 2007
Results First Posted : August 29, 2011
Last Update Posted : November 2, 2011
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: Cytarabine
Drug: Fludarabine
Drug: Oxaliplatin
Drug: Rituximab
Enrollment 48
Recruitment Details Recruitment Period: 11/15/04 to 4/24/07. All patients registered at the University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Oxaliplatin, Fludarabine, Cytarabine + Rituximab
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 48
Completed 48
Not Completed 0
Arm/Group Title Oxaliplatin, Fludarabine, Cytarabine + Rituximab
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 48 participants
61
(37 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
14
  29.2%
Male
34
  70.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants
48
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) Oxaliplatin
Hide Description MTD defined as dose level at which 2/3 or 2/6 participants experience Dose Limiting Toxicity (DLT), where DLTs are any oxaliplatin-related ≥Grade 3 non-hematological toxicity involving a major organ system (brain, heart, kidney, liver, lung) in the National Cancer Institute (NCI) Version 3.0 toxicity scale.
Time Frame From treatment onset to end of each cycle of treatment (every 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 48 study participants, 19 were enrolled in the Phase I MTD group and included in the MTD analysis.
Arm/Group Title Oxaliplatin, Fludarabine, Cytarabine + Rituximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: mg/m^2
25
2.Secondary Outcome
Title Number of Participants With a Complete Response or Partial Response
Hide Description According to International Workshop Response Criteria for Non-Hodgkin's Lymphomas: Complete remission (CR) defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; and Partial remission (PR) defined as > 50% decrease of clinical symptoms from baseline and recovery from blood counts.
Time Frame Evaluation every 3 cycles of treatment (28 days per cycle), approximately 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxaliplatin, Fludarabine, Cytarabine + Rituximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Participants
Complete response (CR) 12
Partial response (PR) 28
Time Frame 1 year, 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxaliplatin, Fludarabine, Cytarabine + Rituximab
Hide Arm/Group Description 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.
All-Cause Mortality
Oxaliplatin, Fludarabine, Cytarabine + Rituximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oxaliplatin, Fludarabine, Cytarabine + Rituximab
Affected / at Risk (%) # Events
Total   28/48 (58.33%)    
Blood and lymphatic system disorders   
Hemolysis  1  1/48 (2.08%)  1
Gastrointestinal disorders   
Dehydration  1  1/48 (2.08%)  1
General disorders   
Death  1  4/48 (8.33%)  4
Fever  1  5/48 (10.42%)  5
Infections and infestations   
Infection  1  11/48 (22.92%)  12
Neutropenic Fever  1  9/48 (18.75%)  11
Respiratory, thoracic and mediastinal disorders   
Left Pleural Effusion  1  1/48 (2.08%)  1
Vascular disorders   
Retinal Hemorrhage  1  1/48 (2.08%)  1
Gastrointestinal Hemorrhage  1  1/48 (2.08%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oxaliplatin, Fludarabine, Cytarabine + Rituximab
Affected / at Risk (%) # Events
Total   48/48 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia  1  48/48 (100.00%)  48
Anemia  1  48/48 (100.00%)  48
Thrombocytopenia  1  48/48 (100.00%)  48
Gastrointestinal disorders   
Nausea  1  13/48 (27.08%)  13
Diarrhea  1  8/48 (16.67%)  8
Constipation  1  5/48 (10.42%)  5
Anorexia  1  3/48 (6.25%)  3
Mucositis  1  4/48 (8.33%)  4
Dehydration  1  3/48 (6.25%)  3
General disorders   
Fatigue  1  20/48 (41.67%)  20
Pain  1  5/48 (10.42%)  5
Nervous system disorders   
Neuropathy  1  4/48 (8.33%)  4
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  4/48 (8.33%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William Wierda, M.D./Associate Professor
Organization: The University of Texas M. D. Anderson Cancer Center
Phone: 713-745-0428
EMail: eharriso@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00452374     History of Changes
Other Study ID Numbers: 2004-0373
First Submitted: March 23, 2007
First Posted: March 27, 2007
Results First Submitted: July 28, 2011
Results First Posted: August 29, 2011
Last Update Posted: November 2, 2011