Conditions: Lymphoma, Mucosa-Associated Lymphoid Tissue
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 454
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: 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) arm 2: rituximab 375 mg/m2 iv, d1, d8, d15, d22 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 arm 3: rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140

Interventions: intervention 1: chlorambucil (drug) intervention 2: rituximab+chlorambucil intervention 3: rituximab
Intervention descriptions: intervention 1: 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) intervention 2: 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 intervention 3: rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140

Protocol document: