Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

Phase 2

Completed

• Conditions: Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
• Interventions: Drug: Rituximab and Lenalidomide

• Registration Number: NCT01611259
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-18
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-04
• Primary Completion: 2014-05
• Study Completion: 2015-02
• Results First Submitted: 2016-06-21
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-19
• Last Update Submitted: 2017-06-19
• Results First Posted: 2017-11-06
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab and Lenalidomide	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

Primary Outcome Measures

Name	Time	Method
Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease	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 Outcome Measures

Name	Time	Method
Number and Severity of Adverse Events	From treatment start until 28 days after last study treatment; expected study duration 24 months	Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population
Influence of Rituximab Plus Lenalidomide on T-cell Subsets	Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5	T-cell subsets will be evaluated from EDTA blood in a central lab

Trial Locations

Locations (5)

PMU Salzburg; 🇦🇹 Salzburg, Austria

AKH Linz; 🇦🇹 Linz, Oberösterreich, Austria

Klin.Abt.f. Hämatologie; Med.Univ.Graz; 🇦🇹 Graz, Austria

Univ.-Klinik f. Innere Medizin V; 🇦🇹 Innsbruck, Austria

Universitätsklinik f. Innere Medizin I; 🇦🇹 Vienna, Austria