Trial Outcomes & Findings for Velcade (Bortezomib, PS-341) and Rituximab in Relapsed/Refractory Mantle Cell and Follicular Non-Hodgkin's Lymphoma (NCT NCT00201877)

NCT ID: NCT00201877

Last Updated: 2018-03-12

Results Overview

To determine the overall survival in patients with relapsed or refractory mantle cell and follicular lymphoma following treatment with rituximab and Velcade™.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Every 3 months

Results posted on

2018-03-12

Participant Flow

From December 2005 until June 2009, 25 patients aged ≥ 18 years with historically confirmed, grade 1 or 2 mantel cell or follicular NHL according to the World Health Organization classification who relapsed or were refractory after at least 1 previous therapy.

Participant milestones

Participant milestones
Measure	Velcade and Rituximab Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration. Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Velcade (Bortezomib, PS-341) and Rituximab in Relapsed/Refractory Mantle Cell and Follicular Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Velcade and Rituximab n=25 Participants Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration. Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants
Lymphoma Disease Stages I(lymph node area or 1 organ outside lymph system	2 participants n=5 Participants
Lymphoma Disease Stages II(2 or more groups of lymph nodes)	1 participants n=5 Participants
Lymphoma Disease Stages Stage III(lymph node areas on both sides)	9 participants n=5 Participants
Lymphoma Disease Stages IV(outside lymph system into organ)	13 participants n=5 Participants
B-symptoms Yes	6 participants n=5 Participants
B-symptoms No	19 participants n=5 Participants
Disease Type Mantle cell lymphoma	14 participants n=5 Participants
Disease Type Follicular lymphoma	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 3 months

To determine the overall survival in patients with relapsed or refractory mantle cell and follicular lymphoma following treatment with rituximab and Velcade™.

Outcome measures

Outcome measures
Measure	Velcade and Rituximab n=25 Participants Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration. Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14
Overall Response Rate All patients	40 percentage of patients
Overall Response Rate Patients with follicular lymphoma	55 percentage of patients
Overall Response Rate Patients with MCL	29 percentage of patients

PRIMARY outcome

Timeframe: Day 1 of each cycle

Population: grade 3 neurotoxicity which consisted of constipation/ileus, sensory or motor neuropathy, or orthostatic hypotension

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.

Outcome measures

Outcome measures
Measure	Velcade and Rituximab n=25 Participants Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration. Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14
Assess the Toxicity of Combination Rituximab and Velcade™ in Patients With Previously Treated Mantle Cell and Follicular Lymphoma.	13 patients

SECONDARY outcome

Timeframe: 2 years

To correlate serial plasma rituximab levels with response and progression-free survival.

Outcome measures

Outcome measures
Measure	Velcade and Rituximab n=25 Participants Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration. Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14
Progression-free Survival(PFS) Responding patients	60 percentage of patients Interval 20.0 to 85.0
Progression-free Survival(PFS) All patients	24 percentage of patients Interval 10.0 to 53.0

SECONDARY outcome

Timeframe: During induction (weeks 1-15); PK every 2 months during maintenance.

Population: Data not collected and analyzed

Outcome measures

Outcome data not reported

Adverse Events

Velcade and Rituximab

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Velcade and Rituximab n=25 participants at risk Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration. Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14
General disorders Neutropenia	12.0% 3/25 • Number of events 3
Blood and lymphatic system disorders Anemia	8.0% 2/25 • Number of events 2
Injury, poisoning and procedural complications Thrombocytopenia	8.0% 2/25 • Number of events 2
Metabolism and nutrition disorders Anorexia	4.0% 1/25 • Number of events 1
Skin and subcutaneous tissue disorders Rash	4.0% 1/25 • Number of events 1
Musculoskeletal and connective tissue disorders Sensory Neuropathy	36.0% 9/25 • Number of events 9
Musculoskeletal and connective tissue disorders Motor Neuropathy	4.0% 1/25 • Number of events 1
Nervous system disorders Autonomic neuropathy	12.0% 3/25 • Number of events 3
Blood and lymphatic system disorders Febrile neutropenia	4.0% 1/25 • Number of events 1
General disorders Fatigue	32.0% 8/25 • Number of events 8
Investigations Myositis/Creatinine kinase elevation	4.0% 1/25 • Number of events 1
Gastrointestinal disorders nausea/vomiting	4.0% 1/25 • Number of events 1
Gastrointestinal disorders Constipation/ileus	12.0% 3/25 • Number of events 3

Additional Information

Kristie Blum, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-4519

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place