Trial Outcomes & Findings for Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma (NCT NCT00401817)

Last Updated: 2017-10-20

Results Overview

Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

38 months

Results posted on

2017-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Study Treatment Arm Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Treatment Arm n=11 Participants Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 38 months

Outcome measures

Outcome measures
Measure	Study Treatment Arm n=11 Participants Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles
Number of Participants With Toxicity	8 participants

SECONDARY outcome

Timeframe: 38 Months (min 33 months, max 62 months)

Population: Evaluable patients

Overall Response Rate measured using Kaplan-Meier survival analysis Response criteria were those reported by Cheson et al. (1999)

Outcome measures

Outcome measures
Measure	Study Treatment Arm n=11 Participants Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles
Overall Response Rate	82 percentage of participants Interval 48.0 to 98.0

SECONDARY outcome

Timeframe: 3 years

Population: Evaluable patients

The percentage of patients who have not progressed at the three year time point. The 3-year PFS rate was estimated based on the Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Study Treatment Arm n=11 Participants Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles
Progression-Free Survival	23 percentage of patients Interval 4.0 to 51.0

SECONDARY outcome

Timeframe: 3 years

Population: Evaluable Patients

The percentage of patients who have survived at the three year time point. The 3-year OS rate was estimated based on the Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Study Treatment Arm n=11 Participants Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles
Overall Survival	82 percentage of patients Interval 45.0 to 95.0

Adverse Events

Study Treatment Arm

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study Treatment Arm n=11 participants at risk Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles
Reproductive system and breast disorders Prostate Cancer	9.1% 1/11 • Number of events 1

Other adverse events

Other adverse events
Measure	Study Treatment Arm n=11 participants at risk Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles
Blood and lymphatic system disorders Neutropenia	27.3% 3/11
Blood and lymphatic system disorders Anemia	72.7% 8/11
Blood and lymphatic system disorders Thrombocytopenia	45.5% 5/11
Infections and infestations Febrile Neutropenia	9.1% 1/11
Infections and infestations Infection (normal ANC)	9.1% 1/11
Cardiac disorders Left ventricular systolic dysfunction	18.2% 2/11
Cardiac disorders Hypertension	9.1% 1/11
Renal and urinary disorders Proteinuria	9.1% 1/11
General disorders Bleeding	9.1% 1/11
Infections and infestations Rituximab infusion rxn	36.4% 4/11
Nervous system disorders Neuropathy	36.4% 4/11
General disorders Fatigue	63.6% 7/11
Blood and lymphatic system disorders Hypocalcemia	36.4% 4/11
General disorders Constipation	27.3% 3/11
General disorders Edema	27.3% 3/11
General disorders Nausea	18.2% 2/11
General disorders Second malignancy	18.2% 2/11
Respiratory, thoracic and mediastinal disorders Pleural effusion	18.2% 2/11
General disorders Mouth sore	18.2% 2/11
Blood and lymphatic system disorders Hyperkalemia	18.2% 2/11
Blood and lymphatic system disorders Hypoalbuminemia	18.2% 2/11
Cardiac disorders Congestive heart failure	9.1% 1/11
General disorders Dyspnea	9.1% 1/11
Metabolism and nutrition disorders Anorexia	9.1% 1/11

Additional Information

John Leonard, MD

Weill Cornell Medicine

Phone: 646.962.2064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place