Trial Outcomes & Findings for Identifying Prognostic Factors in Frontline FCR for Patients With Chronic Lymphocytic Leukemia (CLL) (NCT NCT00759798)
NCT ID: NCT00759798
Last Updated: 2021-09-05
Results Overview
Complete Response defined by NCI Working Group / International Working Group for CLL criteria as no evidence of disease on physical examination (no adenopathy or organomegaly) or microscopic examination of blood (ALC \<4,000/L) and bone marrow (\<30% lymphocytes, no lymphoid nodules), and recovery of hemoglobin, neutrophil, and platelet counts.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
289 participants
Primary outcome timeframe
After 6 months
Results posted on
2021-09-05
Participant Flow
Recruitment Period: August 2008 to April 2016
Participant milestones
| Measure |
Fludarabine, Cyclophosphamide, Rituximab
Fludarabine 25 mg/m\^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
Fludarabine: 25 mg/m\^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
Cyclophosphamide: 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
Rituximab: 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
|
|---|---|
|
Overall Study
STARTED
|
289
|
|
Overall Study
COMPLETED
|
289
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Identifying Prognostic Factors in Frontline FCR for Patients With Chronic Lymphocytic Leukemia (CLL)
Baseline characteristics by cohort
| Measure |
Fludarabine, Cyclophosphamide, Rituximab
n=289 Participants
Fludarabine 25 mg/m\^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
Fludarabine: 25 mg/m\^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
Cyclophosphamide: 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
Rituximab: 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
237 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
256 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
289 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 6 monthsComplete Response defined by NCI Working Group / International Working Group for CLL criteria as no evidence of disease on physical examination (no adenopathy or organomegaly) or microscopic examination of blood (ALC \<4,000/L) and bone marrow (\<30% lymphocytes, no lymphoid nodules), and recovery of hemoglobin, neutrophil, and platelet counts.
Outcome measures
| Measure |
Fludarabine, Cyclophosphamide, Rituximab
n=289 Participants
Fludarabine 25 mg/m\^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
Fludarabine: 25 mg/m\^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
Cyclophosphamide: 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
Rituximab: 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
|
|---|---|
|
Number of Participants With Complete Remission (CR)
|
185 Participants
|
Adverse Events
Fludarabine, Cyclophosphamide, Rituximab
Serious events: 65 serious events
Other events: 0 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Fludarabine, Cyclophosphamide, Rituximab
n=289 participants at risk
Fludarabine 25 mg/m\^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
Fludarabine: 25 mg/m\^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
Cyclophosphamide: 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
Rituximab: 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
|
|---|---|
|
General disorders
Fever
|
5.2%
15/289 • Number of events 18 • Up to 7 years, 8 months
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
7.6%
22/289 • Number of events 23 • Up to 7 years, 8 months
|
|
Infections and infestations
Infection
|
1.0%
3/289 • Number of events 3 • Up to 7 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.69%
2/289 • Number of events 2 • Up to 7 years, 8 months
|
|
General disorders
Abdominal Pain
|
1.0%
3/289 • Number of events 3 • Up to 7 years, 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
1.0%
3/289 • Number of events 3 • Up to 7 years, 8 months
|
|
Infections and infestations
Upper Respiratory Infection
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Infections and infestations
Pneumonia
|
2.8%
8/289 • Number of events 12 • Up to 7 years, 8 months
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Investigations
Hyperbilirubinemia
|
0.35%
1/289 • Number of events 2 • Up to 7 years, 8 months
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Infections and infestations
Bronchitis
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Reproductive system and breast disorders
Perineal Abcess
|
0.35%
1/289 • Number of events 2 • Up to 7 years, 8 months
|
|
Infections and infestations
Cellulitis
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Infections and infestations
staphylococcus Infection Leg
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Infections and infestations
Opportunistic Infection
|
0.69%
2/289 • Number of events 2 • Up to 7 years, 8 months
|
|
General disorders
Pain Lower Extremity
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
General disorders
Flu Like Symptoms
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
|
General disorders
Pain
|
0.35%
1/289 • Number of events 1 • Up to 7 years, 8 months
|
Other adverse events
Adverse event data not reported
Additional Information
William Wierda MD/Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-745-0428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place