Trial Outcomes & Findings for Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma (NCT NCT00547534)

Last Updated: 2015-08-06

Results Overview

To determine the progression-free survival following treatment with the BVR combination in patients with relapsed or refractory indolent and mantle cell non-Hodgkin lymphoma.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Two years

Results posted on

2015-08-06

Participant Flow

Recruitment at the University of Rochester Medical Center, Weill Cornell Medical Center and the University of Nebraska began in October 2007 and ended in March 2009. Patients were recruited in a medial clinic setting.

Participant milestones

Participant milestones
Measure	Lymphoma Subjects Subjects that met all eligibility criteria and were given study treatment.
Overall Study STARTED	30
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Lymphoma Subjects Subjects that met all eligibility criteria and were given study treatment.
Overall Study Adverse Event	7
Overall Study Disease Progression	4

Baseline Characteristics

Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lymphoma Subjects n=30 Participants Subjects that met all eligibility criteria and were given study treatment.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=99 Participants
Age, Categorical >=65 years	14 Participants n=99 Participants
Age, Continuous	64.8 years STANDARD_DEVIATION 20 • n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	22 Participants n=99 Participants
Region of Enrollment United States	30 participants n=99 Participants

PRIMARY outcome

Timeframe: Two years

Population: Analysis was per protocol.

To determine the progression-free survival following treatment with the BVR combination in patients with relapsed or refractory indolent and mantle cell non-Hodgkin lymphoma.

Outcome measures

Outcome measures
Measure	Lymphoma Subjects n=29 Participants Subjects that met all eligibility criteria and were treated.
Number of Participants With Progression Free Survival at 2 Years	13 Participants

SECONDARY outcome

Timeframe: Two years

Outcome measures

Outcome measures
Measure	Lymphoma Subjects n=29 Participants Subjects that met all eligibility criteria and were treated.
Toxicity of Drug Combination in the Subjects	13 Lymphoma Subjects

SECONDARY outcome

Timeframe: Two years

Overall response rate (ORR)to protocol treatment - Partial response, Complete response, etc.

Outcome measures

Outcome measures
Measure	Lymphoma Subjects n=29 Participants Subjects that met all eligibility criteria and were treated.
Overall Response Rate (ORR)	13 Lymphoma Subjects

Adverse Events

Lymphoma Subjects

Serious events: 13 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lymphoma Subjects n=30 participants at risk Subjects that met all eligibility criteria and were given study treatment.
Gastrointestinal disorders Sepsis	3.3% 1/30 • Number of events 1 • Two years
Gastrointestinal disorders Liver Failure	3.3% 1/30 • Number of events 1 • Two years
Endocrine disorders Renal Failure	3.3% 1/30 • Number of events 1 • Two years
Nervous system disorders Peripheral neuropathy	6.7% 2/30 • Number of events 2 • Two years
General disorders Fatigue	6.7% 2/30 • Number of events 2 • Two years
Blood and lymphatic system disorders Hypotension	6.7% 2/30 • Number of events 2 • Two years
Infections and infestations Herpes zoster	6.7% 2/30 • Number of events 2 • Two years
Gastrointestinal disorders Dehydration	6.7% 2/30 • Number of events 2 • Two years

Other adverse events

Other adverse events
Measure	Lymphoma Subjects n=30 participants at risk Subjects that met all eligibility criteria and were given study treatment.
Gastrointestinal disorders Nausea	50.0% 15/30 • Number of events 15 • Two years
Nervous system disorders Peripheral neuropathy	46.7% 14/30 • Number of events 14 • Two years
General disorders Fatigue	46.7% 14/30 • Number of events 14 • Two years
Gastrointestinal disorders Constipation	40.0% 12/30 • Number of events 12 • Two years
General disorders Fever	40.0% 12/30 • Number of events 12 • Two years
Gastrointestinal disorders Diarrhea	26.7% 8/30 • Number of events 8 • Two years
Infections and infestations Cough	23.3% 7/30 • Number of events 7 • Two years
Cardiac disorders Hypotension	20.0% 6/30 • Number of events 6 • Two years
General disorders Rigors / chills	16.7% 5/30 • Number of events 5 • Two years
Musculoskeletal and connective tissue disorders Pain	30.0% 9/30 • Number of events 9 • Two years
Infections and infestations Herpes zoster	13.3% 4/30 • Number of events 4 • Two years
Infections and infestations Allergic reaction	13.3% 4/30 • Number of events 4 • Two years
General disorders Headache	13.3% 4/30 • Number of events 4 • Two years
General disorders Pruritis	10.0% 3/30 • Number of events 3 • Two years
Gastrointestinal disorders Anorexia	10.0% 3/30 • Number of events 3 • Two years
General disorders Dizziness	10.0% 3/30 • Number of events 3 • Two years
Infections and infestations Rash	10.0% 3/30 • Number of events 3 • Two years
Cardiac disorders Shortness of breath	10.0% 3/30 • Number of events 3 • Two years
Gastrointestinal disorders Stomach/abdominal pain	10.0% 3/30 • Number of events 3 • Two years

Additional Information

Dr. Jonathan Friedberg

University of Rochester Medical Center

Phone: 585-275-4911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place