Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue
- Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Study ID
- NCT01611259
- Phase
- PHASE2
- Status
- Completed
Conditions
- Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab and Lenalidomide — DRUGRituximab 375 mg/m² i.v. day 1 Lenalidomide 20 mg p.o. daily for 21 days Cycles should be repeated every 28 days. Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses will stop therapy/study, while patients with PR or SD will be given another two cycles for a maximum of 8 cycles.
Study Details
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.
Key Dates
- Start date
- May 31, 2012
- Status verified
- Jun 2017
- Primary completion
- May 31, 2014
- Completion
- Feb 28, 2015
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Rituximab and LenalidomideSingle 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
Primary Outcome Measure
Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease [ Time Frame: 40 weeks ]