Trial Outcomes & Findings for CFAR Study in Patients With Chronic Lymphocytic Leukemia (NCT NCT00525603)

Last Updated: 2013-03-04

Results Overview

Overall Response: Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. National Cancer Institute - Working Group (NCI-WG) response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)\>1,500/uL, Platelets \>100,000uL, Hemoglobin (untransfused) \>11.0g/dL, Lymphocytes \<4,000/uL and Bone Marrow Aspirate biopsy \<30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes \>/= 50% decrease,Liver/spleen \>/= 50% decrease, symptoms not applicable, PMN \>1,500/uL or \>50% improvement from baseline, Platelets 100,000uL or \>/=50% decrease improvement from baseline, Hemoglobin (untransfused) \>11.0g/dL or \>50% improvement from baseline, Lymphocytes \>50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with \<30% lymphocytes with residual disease on biopsy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Evaluated after 3 courses of 4 week therapy (12 weeks)

Results posted on

2013-03-04

Participant Flow

Recruitment Period 6/24/2005 to 6/21/2007. All participants were registered at The University of Texas M.D. Anderson Cancer Center.

Of the 60 enrolled, 60 eligible participants were included in this study and started study drug.

Participant milestones

Participant milestones
Measure	CFAR Participants received fludarabine 20 mg/m\^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m\^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m\^2 IV on day 2 for C1 and 500mg/m\^2 IV on day 2 for C2-6.
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CFAR Study in Patients With Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CFAR n=60 Participants Participants received fludarabine 20 mg/m\^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m\^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m\^2 IV on day 2 for C1 and 500mg/m\^2 IV on day 2 for C2-6.
Age Continuous	60 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluated after 3 courses of 4 week therapy (12 weeks)

Population: Sixty participants were analyzed for response. Four participants did not have a response and one participant was not evaluable.

Outcome measures

Outcome measures
Measure	CFAR n=60 Participants Participants received fludarabine 20 mg/m\^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m\^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m\^2 IV on day 2 for C1 and 500mg/m\^2 IV on day 2 for C2-6.
Overall Participant Response Complete remission (CR)	44 Participants
Overall Participant Response Nodular partial remission (nPR)	1 Participants
Overall Participant Response Partial remission (PR)	10 Participants

Adverse Events

CFAR

Serious events: 11 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CFAR n=60 participants at risk Participants received fludarabine 20 mg/m\^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m\^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m\^2 IV on day 2 for C1 and 500mg/m\^2 IV on day 2 for C2-6.
General disorders Fever	8.3% 5/60 • Number of events 5 • 5 years 7 months
Metabolism and nutrition disorders Elevated Creatinine	1.7% 1/60 • Number of events 1 • 5 years 7 months
Renal and urinary disorders Acute Renal Failure	1.7% 1/60 • Number of events 1 • 5 years 7 months
Respiratory, thoracic and mediastinal disorders Dyspnea	1.7% 1/60 • Number of events 1 • 5 years 7 months
Infections and infestations Infection	8.3% 5/60 • Number of events 5 • 5 years 7 months
Nervous system disorders Syncope	1.7% 1/60 • Number of events 1 • 5 years 7 months
General disorders Febrile Neutropenia	5.0% 3/60 • Number of events 3 • 5 years 7 months

Other adverse events

Other adverse events
Measure	CFAR n=60 participants at risk Participants received fludarabine 20 mg/m\^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m\^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m\^2 IV on day 2 for C1 and 500mg/m\^2 IV on day 2 for C2-6.
General disorders Drug Reaction	73.3% 44/60 • Number of events 44 • 5 years 7 months
Gastrointestinal disorders Nausea	61.7% 37/60 • Number of events 37 • 5 years 7 months
Gastrointestinal disorders Vomiting	21.7% 13/60 • Number of events 13 • 5 years 7 months
Gastrointestinal disorders Constipation	16.7% 10/60 • Number of events 10 • 5 years 7 months
Infections and infestations Sinusitis	10.0% 6/60 • Number of events 6 • 5 years 7 months
General disorders Fatigue	33.3% 20/60 • Number of events 20 • 5 years 7 months
Gastrointestinal disorders Diarrhea	18.3% 11/60 • Number of events 11 • 5 years 7 months
Cardiac disorders Hypotension	10.0% 6/60 • Number of events 6 • 5 years 7 months
Blood and lymphatic system disorders Anemia	8.3% 5/60 • Number of events 5 • 5 years 7 months
Infections and infestations Urinary Tract Infection	8.3% 5/60 • Number of events 5 • 5 years 7 months
Blood and lymphatic system disorders Neutropenia	5.0% 3/60 • Number of events 3 • 5 years 7 months
Gastrointestinal disorders Anorexia	6.7% 4/60 • Number of events 4 • 5 years 7 months
General disorders Chest Pain	6.7% 4/60 • Number of events 4 • 5 years 7 months
Infections and infestations Upper Respiratory Infection	5.0% 3/60 • Number of events 3 • 5 years 7 months
Skin and subcutaneous tissue disorders Rash	15.0% 9/60 • Number of events 9 • 5 years 7 months
Infections and infestations Infection Other	8.3% 5/60 • Number of events 5 • 5 years 7 months
Infections and infestations Mucositis	5.0% 3/60 • Number of events 3 • 5 years 7 months
General disorders Pain Other	5.0% 3/60 • Number of events 3 • 5 years 7 months

Additional Information

William G. Wierda, MD/Associate Professor

The University of 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