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Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma

NCT00210353 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2019-06-06

Study results available
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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

Conditions

  • Lymphoma, Mucosa-Associated Lymphoid Tissue

Interventions

DRUG

chlorambucil (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)

DRUG

rituximab+chlorambucil

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

DRUG

rituximab

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

Sponsors & Collaborators

  • International Extranodal Lymphoma Study Group (IELSG)

    lead OTHER

Principal Investigators

  • Emanuele Zucca, MD · International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland. Bellinzona

  • Emilio Montserrat, MD · Clinic Hospital Universitari, Hematology. Barcelona

  • Catherine Thieblemont, MD · Centre Hospitalier Lyon Sud, Hematology. Lyon

  • Giovanni Martinelli, MD · Hemato-oncology. European Oncology Institute. Milan

  • Peter Johnson, MD · Oncology Unit. Southampton General Hospital. Southampton

  • Maurizio Martelli, MD · Hematology. Università La Sapienza. Roma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2015-04-30
Completion
2016-02-17

Countries

  • Belgium
  • France
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00210353 on ClinicalTrials.gov