Trial Outcomes & Findings for Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL (NCT NCT00772668)

Results Overview

Rate of overall response (CR, CRu, PR) to protocol therapy according to International Workshop Criteria (IWC): * Complete Response (CR) includes complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL; * Complete Response Unconfirmed (CRu) includes above CR criteria but a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product of the perpendicular diameters (SPD), or indeterminate bone marrow; * Partial Response (PR) includes \>= 50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

Post cycles 2,4,6,8 and then every 3 months, about 2 years

Results posted on

2017-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	RCVELP Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP): * Rituximab * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles * Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles * Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles * Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	RCVELP Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP): * Rituximab * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles * Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles * Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles * Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Overall Study Physician Decision	3

Baseline Characteristics

Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RCVELP n=3 Participants Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP): * Rituximab * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles * Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles * Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles * Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Region of Enrollment United States	3 participants n=93 Participants

PRIMARY outcome

Timeframe: Post cycles 2,4,6,8 and then every 3 months, about 2 years

Population: A minimum enrollment of 30 participants was required for this outcome measure. Due this minimum requirement not being met, and the early termination of the study due to lack of funding, the data for this outcome measure were not analyzed.

Rate of overall response (CR, CRu, PR) to protocol therapy according to International Workshop Criteria (IWC): * Complete Response (CR) includes complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL; * Complete Response Unconfirmed (CRu) includes above CR criteria but a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product of the perpendicular diameters (SPD), or indeterminate bone marrow; * Partial Response (PR) includes \>= 50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Progression free-survival will be assessed according to according to the International Workshop Criteria (IWC). Progression-free survival will be measured as the time from date of enrollment to relapse, progression or death due to follicular lymphoma (FL) or marginal zone lymphoma (MZL), whichever occurs first. Participants who do not experience relapse or progression, and those who die from causes other than cancer, will be censored at the date of last contact.

Outcome measures

Outcome measures
Measure	RCVELP n=3 Participants Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP): * Rituximab * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles * Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles * Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles * Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Progression-free Survival (PFS)	NA months At the time of study termination, all participants were in remission. Progression Free Survival could not be measured as none of the participants progressed, and no mortality events have occurred.

SECONDARY outcome

Timeframe: Up to 5 years

Overall survival (OS) will be measured as the time from date of enrollment to death from any cause. For patients who remain alive, survival time will be censored at the date of last contact.

Outcome measures

Outcome measures
Measure	RCVELP n=3 Participants Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP): * Rituximab * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles * Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles * Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles * Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Overall Survival (OS)	NA months At the time of study termination, all participants were still alive. Overall Survival could not be measured as no mortality events have occurred.

SECONDARY outcome

Timeframe: Up to 5 years

Safety and tolerance to protocol therapy as evidenced by the rate of toxicity (serious adverse events and study-related adverse events) in study participants

Outcome measures

Outcome measures
Measure	RCVELP n=3 Participants Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP): * Rituximab * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles * Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles * Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles * Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Rate of Toxicity in Study Participants	1 participants

Adverse Events

RCVELP

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RCVELP n=3 participants at risk Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP): * Rituximab * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles * Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles * Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles * Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Gastrointestinal disorders Diverticulitis, Grade 3	33.3% 1/3 • Number of events 1 No non-serious study related adverse events were reported.

Other adverse events

Adverse event data not reported

Additional Information

Denise Pereira MD

UM/Sylvester Comprehensive Cancer

Phone: 305-243-9127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place