Phase II Trial of Rituximab Plus Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
Overview
- Phase
- Phase 2
- Intervention
- Rituximab and Lenalidomide
- Conditions
- Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
- Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Enrollment
- 50
- Locations
- 5
- Primary Endpoint
- Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Rituximab and Lenalidomide
Single arm: 6 cycles for patients with complete response, 8 cycles for subjects with stable disease or partial remission; cycles duration: 28 days Rituximab (Mabthera®): 375 mg/m² i.v. day 1 Lenalidomide (Revlimid®): 20 mg p.o. daily for 21 days
Intervention: Rituximab and Lenalidomide
Outcomes
Primary Outcomes
Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease
Time Frame: 40 weeks
The primary objective of this Phase II study is to evaluate the proportion of patients responding to Lenalidomide and Rituximab. In case of a response rate of \< 40%, the combination is rejected as ineffective, while an active combination is defined at a minimum response rate of 60% based of findings with rituximab and lenalidomide mono-therapy.
Secondary Outcomes
- Number and Severity of Adverse Events(From treatment start until 28 days after last study treatment; expected study duration 24 months)
- Influence of Rituximab Plus Lenalidomide on T-cell Subsets(Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5)