NCT00210353

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: International Extranodal Lymphoma Study Group (IELSG) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2003-01-01
• Primary completion: 2015-04-01
• Completion: 2016-02-17
• First posted: 2005-09-21
• Last updated: 2019-06-06
• Results posted: 2019-06-06

Locations

75 sites across 6 countries: Belgium, France, Italy, Spain, Switzerland, United Kingdom