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Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

NCT01611259 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-11-06

Study results available
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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.

Conditions

  • Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Interventions

DRUG

Rituximab and Lenalidomide

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.

Sponsors & Collaborators

  • Arbeitsgemeinschaft medikamentoese Tumortherapie

    lead OTHER

Principal Investigators

  • Markus Raderer, MD · Allgemeines Krankenhaus der Stadt Wien - Medizinischer Universitätscampus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-05-31
Completion
2015-02-28

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01611259 on ClinicalTrials.gov