drugset / Trial / NCT00210353
Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2003-01
- Primary completion
- 2015-04
- Completion
- 2016-02-17
Publications
- Bommier C, Zucca E, Chevret S, Conconi A, Nowakowski G, Maurer MJ, Cerhan JR, Thieblemont C, Lambert J. Early complete response as a validated surrogate marker in extranodal marginal zone lymphoma systemic therapy. Blood. 2024 Feb 1;143(5):422-428. doi: 10.1182/blood.2023020984.
- Zucca E, Conconi A, Laszlo D, Lopez-Guillermo A, Bouabdallah R, Coiffier B, Sebban C, Jardin F, Vitolo U, Morschhauser F, Pileri SA, Copie-Bergman C, Campo E, Jack A, Floriani I, Johnson P, Martelli M, Cavalli F, Martinelli G, Thieblemont C. Addition of rituximab to chlorambucil produces superior event-free survival in the treatment of patients with extranodal marginal-zone B-cell lymphoma: 5-year analysis of the IELSG-19 Randomized Study. J Clin Oncol. 2013 Feb 10;31(5):565-72. doi: 10.1200/JCO.2011.40.6272. Epub 2013 Jan 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Chlorambucil | Other / unclassified | 6 mg/m2 | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |