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| Sponsored by: |
International Extranodal Lymphoma Study Group (IELSG) |
|---|---|
| Information provided by: | International Extranodal Lymphoma Study Group (IELSG) |
| ClinicalTrials.gov Identifier: | NCT00210353 |
Purpose
Aim of the study is to assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and to determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Mucosa-Associated Lymphoid Tissue |
Drug: rituximab (drug) Drug: chlorambucil (drug) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Multicenter Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab in Extranodal Marginal Zone B-Cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma) |
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2003 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Cristina Morinini | +41 91 8119040 | ielsg@ticino.com |
| Switzerland | |
| Oncology Institute of Southern Switzerland - Ospedale San Giovanni | Recruiting |
| Bellinzona, Switzerland, 6500 | |
| Contact: Cristina Morinini +41 91 8119040 ielsg@ticino.com | |
| Study Chair: | Emanuele Zucca, MD | International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland. Bellinzona |
| Study Chair: | Emilio Montserrat, MD | Clinic Hospital Universitari, Hematology. Barcelona |
| Study Chair: | Catherine Thieblemont, MD | Centre Hospitalier Lyon Sud, Hematology. Lyon |
| Study Chair: | Giovanni Martinelli, MD | Hemato-oncology. European Oncology Institute. Milan |
| Study Chair: | Peter Johnson, MD | Oncology Unit. Southampton General Hospital. Southampton |
| Study Chair: | Maurizio Martelli, MD | Hematology. Università La Sapienza. Roma |
More Information
| Study ID Numbers: | IELSG19 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 13, 2005 |
| ClinicalTrials.gov Identifier: | NCT00210353 History of Changes |
| Health Authority: | Switzerland: Swissmedic |
|
Immunoproliferative Disorders Immunologic Factors Rituximab Chlorambucil Lymphoma, B-Cell, Marginal Zone Lymphoma, B-Cell Lymphatic Diseases |
B-cell Lymphomas Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Alkylating Agents |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Rituximab Chlorambucil Physiological Effects of Drugs Lymphoma, B-Cell, Marginal Zone Pharmacologic Actions |
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Therapeutic Uses Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Alkylating Agents Lymphoma |