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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Rituximab 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.
AKH Linz
Linz, Upper Austria, Austria
Klin.Abt.f. Hämatologie; Med.Univ.Graz
Graz, Austria
Univ.-Klinik f. Innere Medizin V
Innsbruck, Austria
PMU Salzburg
Salzburg, Austria
Universitätsklinik f. Innere Medizin I
Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease
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.
Time frame: 40 weeks
Number and Severity of Adverse Events
Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population
Time frame: From treatment start until 28 days after last study treatment; expected study duration 24 months
Influence of Rituximab Plus Lenalidomide on T-cell Subsets
T-cell subsets will be evaluated from EDTA blood in a central lab
Time frame: Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5
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Vienna, Austria