Trial Outcomes & Findings for Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma (NCT NCT00581776)

Last Updated: 2019-12-17

Results Overview

Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy. 1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

At completion of induction therapy (21 weeks)

Results posted on

2019-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	VCR-CVAD With Rituximab Maintenance
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	VCR-CVAD With Rituximab Maintenance
Overall Study Disease progression or no response	3

Baseline Characteristics

Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VCR-CVAD With Rituximab Maintenance n=30 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	61 years STANDARD_DEVIATION 26 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: At completion of induction therapy (21 weeks)

Outcome measures

Outcome measures
Measure	VCR-CVAD With Rituximab Maintenance n=30 Participants
Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).	90 Percent of participants Interval 73.0 to 98.0

PRIMARY outcome

Timeframe: at 21 weeks

Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable.

Outcome measures

Outcome measures
Measure	VCR-CVAD With Rituximab Maintenance n=30 Participants
Complete Response Rate (CR) at the End of Induction Chemotherapy	77 percent of participants Interval 73.0 to 98.0

SECONDARY outcome

Timeframe: 36 months

This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study.

Outcome measures

Outcome measures
Measure	VCR-CVAD With Rituximab Maintenance n=30 Participants
3 Year Progression Free Survival	63 percent of participants Interval 48.0 to 83.0

SECONDARY outcome

Timeframe: 36 months

This is the percent of participants who were still alive at 3 years after study entry.

Outcome measures

Outcome measures
Measure	VCR-CVAD With Rituximab Maintenance n=30 Participants
3 Year Overall Survival (OS)	86 Percent of participants Interval 75.0 to 100.0

Adverse Events

VCR-CVAD With Rituximab Maintenance

Serious events: 18 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VCR-CVAD With Rituximab Maintenance n=30 participants at risk
Musculoskeletal and connective tissue disorders Pain	3.3% 1/30 • Number of events 1 • Adverse Event collection with 42 months median follow up
Investigations febrile neutropenia	13.3% 4/30 • Number of events 4 • Adverse Event collection with 42 months median follow up
Infections and infestations Infection	30.0% 9/30 • Number of events 9 • Adverse Event collection with 42 months median follow up
Gastrointestinal disorders Dehydration Gr 3	6.7% 2/30 • Number of events 2 • Adverse Event collection with 42 months median follow up
Renal and urinary disorders Creatinine Gr 2	3.3% 1/30 • Number of events 1 • Adverse Event collection with 42 months median follow up
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	3.3% 1/30 • Number of events 1 • Adverse Event collection with 42 months median follow up
Gastrointestinal disorders Mucositis - Esophagitis	3.3% 1/30 • Number of events 1 • Adverse Event collection with 42 months median follow up
Cardiac disorders Thrombus	6.7% 2/30 • Number of events 2 • Adverse Event collection with 42 months median follow up
Blood and lymphatic system disorders myelosuppression	6.7% 2/30 • Number of events 2 • Adverse Event collection with 42 months median follow up
General disorders progressive disease	3.3% 1/30 • Number of events 1 • Adverse Event collection with 42 months median follow up

Other adverse events

Other adverse events
Measure	VCR-CVAD With Rituximab Maintenance n=30 participants at risk
Investigations Thrombocytopenia Gr 3 or 4	76.7% 23/30 • Adverse Event collection with 42 months median follow up
Investigations Neutropenia gr 3 or 4	66.7% 20/30 • Adverse Event collection with 42 months median follow up
Investigations Hemoglobin gr 3	26.7% 8/30 • Adverse Event collection with 42 months median follow up
Injury, poisoning and procedural complications Febrile Neutropenia gr 3	16.7% 5/30 • Adverse Event collection with 42 months median follow up
Infections and infestations Infection with neutropenia	6.7% 2/30 • Adverse Event collection with 42 months median follow up
Infections and infestations Infection without neutropenia	13.3% 4/30 • Adverse Event collection with 42 months median follow up
Investigations Hyperglycemia gr 3	13.3% 4/30 • Adverse Event collection with 42 months median follow up
Investigations hyponatremia gr 3	13.3% 4/30 • Adverse Event collection with 42 months median follow up
Investigations Hypophosphatemia gr 3	3.3% 1/30 • Adverse Event collection with 42 months median follow up
Gastrointestinal disorders Dehydration gr 3	6.7% 2/30 • Adverse Event collection with 42 months median follow up
Cardiac disorders Pulmonary Embolism Gr 4	3.3% 1/30 • Adverse Event collection with 42 months median follow up
Gastrointestinal disorders Esophagitis Gr 3	3.3% 1/30 • Adverse Event collection with 42 months median follow up
Nervous system disorders Mood alteration Gr 3	3.3% 1/30 • Adverse Event collection with 42 months median follow up
Nervous system disorders Pain gr 3	6.7% 2/30 • Adverse Event collection with 42 months median follow up
Nervous system disorders Sensory neuropathy gr 3 and 4	30.0% 9/30 • Adverse Event collection with 42 months median follow up
General disorders Fatigue gr 3	6.7% 2/30 • Adverse Event collection with 42 months median follow up
Immune system disorders hypogammaglobulinemia	54.5% 12/22 • Adverse Event collection with 42 months median follow up
Infections and infestations Infections secondary to hypogammaglobulinemia in maintenance therapy	27.3% 6/22 • Number of events 9 • Adverse Event collection with 42 months median follow up
Investigations delayed neutropenia during rituximab maintenance	22.7% 5/22 • Number of events 6 • Adverse Event collection with 42 months median follow up

Additional Information

Brad S Kahl

University of Wisconsin- Madison

Phone: 608-263-1836

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60