Trial Outcomes & Findings for Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) (NCT NCT01082939)

Last Updated: 2012-02-20

Results Overview

Overall (OR) is the total number of participants with any response: Complete remission (CR), is defined as \> 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; Nodular partial remission (NPR), is the same as CR but with nodules; Partial remission (PR) is \> 50% decrease of clinical symptoms from baseline and recovery from blood counts.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

6 cycles of treatment (28 days per cycle)

Results posted on

2012-02-20

Participant Flow

Recruitment Period 12/6/02- 9/22/06; all participants were registered at The University of Texas M.D. Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	CFAR CFAR: Cyclophosphamide 250 mg/m\^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m\^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m\^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m\^2/day IV Day 2 over 4- 6 hours.
Overall Study STARTED	80
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CFAR n=80 Participants CFAR: Cyclophosphamide 250 mg/m\^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m\^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m\^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m\^2/day IV Day 2 over 4- 6 hours.
Age Continuous	59.5 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 cycles of treatment (28 days per cycle)

Outcome measures

Outcome measures
Measure	CFAR n=80 Participants CFAR: Cyclophosphamide 250 mg/m\^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m\^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m\^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m\^2/day IV Day 2 over 4- 6 hours.
Number of Participants With an Overall Response Complete remission (CR)	23 Participants
Number of Participants With an Overall Response Nodular partial remission (NPR)	3 Participants
Number of Participants With an Overall Response Partial remission (PR)	26 Participants

Adverse Events

CFAR

Serious events: 35 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CFAR n=80 participants at risk CFAR: Cyclophosphamide 250 mg/m\^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m\^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m\^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m\^2/day IV Day 2 over 4- 6 hours.
Infections and infestations Infection	27.5% 22/80 • Number of events 33 • 9 years
Gastrointestinal disorders Mucositis	1.2% 1/80 • Number of events 1 • 9 years
Gastrointestinal disorders Dehydration	1.2% 1/80 • Number of events 1 • 9 years
Cardiac disorders Hypotension	1.2% 1/80 • Number of events 1 • 9 years
General disorders fever	12.5% 10/80 • Number of events 11 • 9 years
Gastrointestinal disorders Nausea	1.2% 1/80 • Number of events 1 • 9 years
Gastrointestinal disorders Vomiting	2.5% 2/80 • Number of events 2 • 9 years
General disorders Allergic Reaction	1.2% 1/80 • Number of events 1 • 9 years
Gastrointestinal disorders Small Bowel Obstruction	1.2% 1/80 • Number of events 1 • 9 years
Cardiac disorders Chest pain	1.2% 1/80 • Number of events 1 • 9 years
Renal and urinary disorders Acute renal failure	1.2% 1/80 • Number of events 1 • 9 years
General disorders Death	3.8% 3/80 • Number of events 3 • 9 years

Other adverse events

Other adverse events
Measure	CFAR n=80 participants at risk CFAR: Cyclophosphamide 250 mg/m\^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m\^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m\^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m\^2/day IV Day 2 over 4- 6 hours.
Blood and lymphatic system disorders Autoimmune hemolytic anemia	5.0% 4/80 • Number of events 4 • 9 years
Blood and lymphatic system disorders Autoimmune thrombocytopenia	2.5% 2/80 • Number of events 2 • 9 years
Blood and lymphatic system disorders Pure red cell aplasia	3.8% 3/80 • Number of events 3 • 9 years
Immune system disorders Cytomegalovirus Reactivation	11.2% 9/80 • Number of events 9 • 9 years
General disorders drug reaction	50.0% 40/80 • Number of events 40 • 9 years
Skin and subcutaneous tissue disorders rash	40.0% 32/80 • Number of events 32 • 9 years
Gastrointestinal disorders Nausea	41.2% 33/80 • Number of events 33 • 9 years
Gastrointestinal disorders Diarrhea	10.0% 8/80 • Number of events 8 • 9 years

Additional Information

William G. Wierda, MD, PhD, BS / Associate 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