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)

NCT00210353 Phase 3 COMPLETED Results posted

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

Details

Lead sponsor	International Extranodal Lymphoma Study Group (IELSG)
Phase	Phase 3
Status	COMPLETED
Enrolment	454
Start date	2003-01
Completion	2016-02-17

Conditions

• Lymphoma, Mucosa-Associated Lymphoid Tissue

Interventions

• chlorambucil (drug)
• rituximab+chlorambucil
• rituximab

Primary outcomes

• Event-free-survival (EFS) — 5 years
  Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration

Countries

Belgium, France, Italy, Spain, Switzerland, United Kingdom