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Rituximab

Lenalidomide

Antineoplastic Agents, Immunological

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

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

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.

Rituximab and Lenalidomide

Markus Raderer, MD

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.

Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

Phase II Trial of Rituximab Plus Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type

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.

Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population

T-cell subsets will be evaluated from EDTA blood in a central lab

Arbeitsgemeinschaft medikamentoese Tumortherapie

Rituximab was administered on day 1 of each cycle in a dose of 375 mg/m² (28 day cycle). Dose of lenalidomide for investigation is 20 mg/day, orally on days 1 to 21 followed by 7 days pause.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 stopped therapy/study, while patients with PR or SD were given another two cycles for a maximum of 8 cycles.

Age, Continuous

Sex: Female, Male

Two of the enrolled patients withdrew their consent prior to study treatment and did not experience adverse events due to other study procedures. These 2 patients were therefore excluded from intent-to-treat (ITT) and per-protocol (PP) efficacy assessments, safety assessments and listing of baseline characteristics.

Public contact Daniela Wolkersdorfer

48 patients were included into safety assessment, two of them received treatment but no efficacy assessment was available. Therefore, these two patients were neither included into Intention-to-treat nor Per-protocol efficacy analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue	NCT01611259	Lymphoma of the...	Rituximab and L...	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie
Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue	NCT01611259	Lymphoma of the...	Rituximab and L...	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie

Spots Global Cancer Trial Database for lymphoma of the mucosa associated lymphoid tissue (malt)