At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 50 enrolled

Drug / intervention

Rituximab and Lenalidomidedrug

Likely dose

Rituximab and Lenalidomide 375 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01611259

NCT01611259Phase 2Completed

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

Arbeitsgemeinschaft medikamentoese Tumortherapie·interventional·Posted Jun 4, 2012·Updated Nov 6, 2017

In Brief

A Phase 2 clinical trial evaluating Rituximab and Lenalidomide for Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT). Completed, enrolled 50 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

CountriesAustria

Collaborators--

Timeline

Phase 2CompletedFinished

201220132014201520162017201820192020202120222023202420252026

Enrollment StartMay 2012

First PostedJun 2012

Primary CompletionMay 2014

Study CompletionFeb 2015

TodayJul 2026

First PostedJun 4, 2012

Enrollment StartMay 1, 2012

Primary CompletionMay 1, 2014

Study CompletionFeb 1, 2015

TodayJul 2, 2026

Enrollment to primary: 2 yearsPosted 14.1 years ago

Interventions

Rituximab and Lenalidomidedrug

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.