At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 454 enrolled

Drug / intervention

chlorambucil (drug) +2 moredrug

Likely dose

Rituximab 375 mg/m² IV weekly × 4 weeks, then at day 1 of each 4-week cycle; Chlorambucil 6 mg/m² orally daily for first 6 weeks, then daily for first 2 weeks of each 4-week cycle × 4 cycles totalAI-extracted

Key inclusion· 8

✓Histologically proven CD20-positive marginal zone B-cell lymphoma of MALT type at any extranodal site
✓Any stage (Ann Arbor I-IV)
✓De novo or relapsed disease following local therapy (surgery, radiotherapy, antibiotics for H. pylori)
✓No evidence of histologic transformation to high-grade lymphoma

Key exclusion· 8

✕Prior chemotherapy
✕Prior anti-CD20 monoclonal antibody immunotherapy
✕Radiotherapy within 6 weeks
✕Corticosteroids within 28 days (unless chronic low-dose ≤20 mg/day for non-lymphoma indication)

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

Search/NCT00210353

NCT00210353Phase 3Completed

Compare CT.gov

Multicenter Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma)

International Extranodal Lymphoma Study Group (IELSG)·interventional·Posted Sep 21, 2005·Updated Jun 6, 2019

In Brief

A Phase 3 clinical trial evaluating chlorambucil (drug), rituximab+chlorambucil, and 1 other intervention for Lymphoma, Mucosa-Associated Lymphoid Tissue. Completed, enrolled 454 participants across 75 sites in 6 countries.

Detailed Summary

Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone. In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLymphoma, Mucosa-Associated Lymphoid Tissue

CountriesBelgium, France, Italy, Spain, Switzerland, United Kingdom

Collaborators--

Timeline

Phase 3CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2003

First PostedSep 2005

Primary CompletionApr 2015

Study CompletionFeb 2016

TodayJul 2026

First PostedSep 21, 2005

Enrollment StartJan 1, 2003

Primary CompletionApr 1, 2015

Study CompletionFeb 17, 2016

TodayJul 2, 2026

Enrollment to primary: 12.3 yearsPosted 20.8 years ago

Interventions

chlorambucil (drug)drug

chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)

rituximab+chlorambucildrug

rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle

rituximabdrug

rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140