Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

June 19, 2017 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8036
        • Klin.Abt.f. Hämatologie; Med.Univ.Graz
      • Innsbruck, Austria, A-6020
        • Univ.-Klinik f. Innere Medizin V
      • Salzburg, Austria, 5020
        • PMU Salzburg
      • Vienna, Austria, 1190
        • Universitätsklinik f. Innere Medizin I
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4021
        • AKH Linz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria selected:

  • Histologically verified diagnosis if MALT lymphoma of any localization
  • Measurable disease upon diagnosis or first or greater relapse after local therapy, prior chemotherapy orHP-eradication. In addition, also in patients with gastric MALT-lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successfulHP-eradication will be included in the study. Patients with gastric MALT lymphoma and no evidence of HP-infection may be enrolled immediately
  • Ann Arbor Stage I-IV
  • In case of prior treatment with Rituximab, the presence of CD20 on lymphoma cells must have been demonstrated before inclusion in the trial.
  • ECOG performance status of 0,1 or 2
  • Patient must be able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin

Exclusion Criteria selected:

  • Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma ("high grade lymphoma") - component
  • Use of any investigational agent within 28 days prior to initiation of treatment with lenalidomide
  • History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
  • Major surgery, other than diagnostic surgery, within the last 4 weeks
  • Evidence of CNS involvement
  • A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
  • Severe peripheral polyneuropathy
  • Clinically significant cardiac disease or myocardial infarction within the last 6 months
  • Known hypersensitivity to thalidomide or lenalidomide or rituximab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease
Time Frame: 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.
40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Severity of Adverse Events
Time Frame: 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
From treatment start until 28 days after last study treatment; expected study duration 24 months
Influence of Rituximab Plus Lenalidomide on T-cell Subsets
Time Frame: 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
Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Investigators

  • Principal Investigator: Markus Raderer, MD, Allgemeines Krankenhaus der Stadt Wien - Medizinischer Universitätscampus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

May 18, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (Estimate)

June 4, 2012

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGMT_MALT2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Clinical Trials on Rituximab and Lenalidomide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe