Trial Outcomes & Findings for Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Richter's Syndrome, Refractory CLL and PLL (NCT NCT00452374)
NCT ID: NCT00452374
Last Updated: 2011-11-02
Results Overview
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.
COMPLETED
PHASE1/PHASE2
48 participants
From treatment onset to end of each cycle of treatment (every 21 days)
2011-11-02
Participant Flow
Recruitment Period: 11/15/04 to 4/24/07. All patients registered at the University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Richter's Syndrome, Refractory CLL and PLL
Baseline characteristics by cohort
| Measure |
Oxaliplatin, Fludarabine, Cytarabine + Rituximab
n=48 Participants
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.
|
|---|---|
|
Age Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From treatment onset to end of each cycle of treatment (every 21 days)Population: Of the 48 study participants, 19 were enrolled in the Phase I MTD group and included in the MTD analysis.
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.
Outcome measures
| Measure |
Oxaliplatin, Fludarabine, Cytarabine + Rituximab
n=19 Participants
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.
|
|---|---|
|
Maximum Tolerated Dose (MTD) Oxaliplatin
|
25 mg/m^2
|
SECONDARY outcome
Timeframe: Evaluation every 3 cycles of treatment (28 days per cycle), approximately 90 daysAccording 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.
Outcome measures
| Measure |
Oxaliplatin, Fludarabine, Cytarabine + Rituximab
n=48 Participants
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.
|
|---|---|
|
Number of Participants With a Complete Response or Partial Response
Complete response (CR)
|
12 Participants
|
|
Number of Participants With a Complete Response or Partial Response
Partial response (PR)
|
28 Participants
|
Adverse Events
Oxaliplatin, Fludarabine, Cytarabine + Rituximab
Serious adverse events
| Measure |
Oxaliplatin, Fludarabine, Cytarabine + Rituximab
n=48 participants at risk
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.
|
|---|---|
|
Infections and infestations
Infection
|
22.9%
11/48 • Number of events 12 • 1 year, 9 months
|
|
Infections and infestations
Neutropenic Fever
|
18.8%
9/48 • Number of events 11 • 1 year, 9 months
|
|
Gastrointestinal disorders
Dehydration
|
2.1%
1/48 • Number of events 1 • 1 year, 9 months
|
|
General disorders
Death
|
8.3%
4/48 • Number of events 4 • 1 year, 9 months
|
|
General disorders
Fever
|
10.4%
5/48 • Number of events 5 • 1 year, 9 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.1%
1/48 • Number of events 1 • 1 year, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Left Pleural Effusion
|
2.1%
1/48 • Number of events 1 • 1 year, 9 months
|
|
Vascular disorders
Retinal Hemorrhage
|
2.1%
1/48 • Number of events 1 • 1 year, 9 months
|
|
Vascular disorders
Gastrointestinal Hemorrhage
|
2.1%
1/48 • Number of events 1 • 1 year, 9 months
|
Other adverse events
| Measure |
Oxaliplatin, Fludarabine, Cytarabine + Rituximab
n=48 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
48/48 • Number of events 48 • 1 year, 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
48/48 • Number of events 48 • 1 year, 9 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
48/48 • Number of events 48 • 1 year, 9 months
|
|
General disorders
Fatigue
|
41.7%
20/48 • Number of events 20 • 1 year, 9 months
|
|
Gastrointestinal disorders
Nausea
|
27.1%
13/48 • Number of events 13 • 1 year, 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
8/48 • Number of events 8 • 1 year, 9 months
|
|
Gastrointestinal disorders
Constipation
|
10.4%
5/48 • Number of events 5 • 1 year, 9 months
|
|
General disorders
Pain
|
10.4%
5/48 • Number of events 5 • 1 year, 9 months
|
|
Gastrointestinal disorders
Anorexia
|
6.2%
3/48 • Number of events 3 • 1 year, 9 months
|
|
Gastrointestinal disorders
Mucositis
|
8.3%
4/48 • Number of events 4 • 1 year, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
4/48 • Number of events 4 • 1 year, 9 months
|
|
Nervous system disorders
Neuropathy
|
8.3%
4/48 • Number of events 4 • 1 year, 9 months
|
|
Gastrointestinal disorders
Dehydration
|
6.2%
3/48 • Number of events 3 • 1 year, 9 months
|
Additional Information
William Wierda, M.D./Associate Professor
The University of Texas M. D. Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place