Trial Outcomes & Findings for Avastin Plus Rituximab for Patients With B-Cell Non-Hodgkin's Lymphoma (NCT NCT00081861)

Results Overview

Response criteria according to the International Working Group Recommendations for lymphoma where Complete Response (CR) defined as "complete disappearance" of clinically detectable disease and Progressive Disease defined by disease appearance by complete blood count (CBC), clinical and radiologic findings, and/or sizes of lymph nodes, spleen, and liver. Response measured from first documentation of response to first detection of progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab),

Results posted on

2012-04-05

Participant Flow

Recruitment Period: April 2004 through November 2006. All participants recruited at U.T. M.D. Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Avastin + Rituximab Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m\^2 intravenously weekly for 8 doses.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Avastin Plus Rituximab for Patients With B-Cell Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Avastin + Rituximab n=13 Participants Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m\^2 intravenously weekly for 8 doses.
Age Continuous	67 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab),

Population: Two participants received first treatment dose but were not eligible for response.

Response criteria according to the International Working Group Recommendations for lymphoma where Complete Response (CR) defined as "complete disappearance" of clinically detectable disease and Progressive Disease defined by disease appearance by complete blood count (CBC), clinical and radiologic findings, and/or sizes of lymph nodes, spleen, and liver. Response measured from first documentation of response to first detection of progression.

Outcome measures

Outcome measures
Measure	Avastin + Rituximab n=11 Participants Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m\^2 intravenously weekly for 8 doses.
Number of Participants With Response (Complete Response or Progressive Disease) Complete Response	2 Participants
Number of Participants With Response (Complete Response or Progressive Disease) Progressive Disease	6 Participants

Adverse Events

Avastin + Rituximab

Serious events: 12 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Avastin + Rituximab n=13 participants at risk Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m\^2 intravenously weekly for 8 doses.
Investigations Pain	23.1% 3/13 • 2 years, 7 months
General disorders Fatigue	15.4% 2/13 • 2 years, 7 months
Cardiac disorders Hypertension	7.7% 1/13 • 2 years, 7 months
Cardiac disorders Hypotension	7.7% 1/13 • 2 years, 7 months
Blood and lymphatic system disorders Hyponatremia	7.7% 1/13 • 2 years, 7 months
Infections and infestations Infection	30.8% 4/13 • 2 years, 7 months

Other adverse events

Other adverse events
Measure	Avastin + Rituximab n=13 participants at risk Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m\^2 intravenously weekly for 8 doses.
Gastrointestinal disorders Diarrhea	30.8% 4/13 • 2 years, 7 months
Blood and lymphatic system disorders Anemia	30.8% 4/13 • 2 years, 7 months
Musculoskeletal and connective tissue disorders Rigors/Chills	30.8% 4/13 • 2 years, 7 months
Cardiac disorders Hypertension	30.8% 4/13 • 2 years, 7 months

Additional Information

Barbara Pro, MD / Associate Professor

U.T. M.D. Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place