Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in treatment-naive patients with non-bulky follicular non-Hodgkin's lymphoma. The anticipated time on study treatment is 3 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab [MabThera/Rituxan] | Drug | 375 mg/m2 intravenously once a week for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall objective complete response rate | Day 50 | |
| Overall objective partial response rate | Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 7 years | |
| Overall survival | 7 years | |
| Duration of response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers | 49033 | France | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 7 years |
| Safety: Incidence of adverse events | 7 years |
| Level of biological marker bcl2 in peripheral blood and bone marrow | 7 years |
| Besançon |
| 25030 |
| France |
| Bordeaux | 33076 | France |
| Clamart | 92141 | France |
| Créteil | 94010 | France |
| Le Mans | 72015 | France |
| Lyon | 69373 | France |
| Nantes | 44093 | France |
| Nice | 06202 | France |
| Paris | 75475 | France |
| Paris | 75571 | France |
| Pierre-Bénite | 69495 | France |
| Poitiers | 86021 | France |
| Rouen | 76038 | France |
| Tours | 37044 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided