NCT01153971CompletedPhase 2
An Open-label Study of Fludarabine and Cyclophosphamide Plus MabThera Followed by Maintenance With MabThera on Failure-free Survival in Treatment-naïve Patients With Advanced Indolent B-cell Nonfollicular Lymphoma
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 47
- Locations
- 15
- Primary Endpoint
- Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date
Study Overview
Brief Summary
This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients 18-65 years of age;
- •previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
- •active disease;
- •>=3 involved sites.
Exclusion Criteria
- •typical chronic lymphocytic leukemia;
- •other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
- •systemic corticosteroid use for >1 month;
- •significant cardiovascular disease;
- •central nervous system involvement;
- •hepatitis B or C virus infection, or HIV infection.
Arms & Interventions
1
Experimental
Intervention: rituximab (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date
Time Frame: Month 28
Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures.
Secondary Outcomes
- Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase(Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase))
- Percentage of Participants Achieving a Response by Response Type and Study Phase(Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40)
- Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- FFS - Percentage of Participants With an Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- FFS - Time to Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- Overall Survival (OS) - Percentage of Participants Estimated to be Alive(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- OS - Percentage of Participants With an Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.)
- OS - Time to Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.)
- DFS - Percentage of Participants With an Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.)
- DFS - Time to Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.)
- Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- PFS - Percentage of Participants With an Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- PFS - Time to Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- DR - Percentage of Participants With an Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
- DR - Time to Event(Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40)
Investigators
Study Sites (15)
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