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| Name | Class |
|---|---|
| Lymphoma Study Association | OTHER |
| Janssen-Cilag Ltd. | INDUSTRY |
| Mundipharma Pte Ltd. | INDUSTRY |
| Roche Pharma AG |
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Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or refuse receive conditioning regimen followed by autograft.
Demonstration of Improvement of progression-free survival (PFS) compared to literature data. 6 months prolongation equal 24 months compared to 18 months obtained whatever the current regimen and in particular compared to RCHOP regimen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RiBVD | Experimental | Rituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RiBVD | Drug | Every cycle: Rituximab intravenous infusion dosage 375 mg/m² day 1 Bendamustine direct intervenous 90 mg/m² day 1 and day 2 Velcade®subcutaneous 1,3 mg/m² day 1,4, 8 and 11 dexamethasone 40 mg IVD on day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of progression-free survival (PFS) | Improvement of progression-free survival (PFS) compared to litterature data 6 months prolongation 24 months compared to 18 months obtained whatever the current regimen and in particular compared to RCHOP regimen in reference with Lenz JCO 2005 | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall and complete response rate after 4 cures and 6 cures | Overall and complete response rate after 4 cures equal intermediate response and after 6 cures equal final response according to Cheson 1999 criteria without Positron Emission Tomography and 2007 with Positron Emission Tomography | 6 months |
| Residual disease evaluated by molecular biology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rémy GRESSIN, MD | Groupe Est Ouest des Leucémies et autres Maladies du Sand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valerie ROLLAND NEYRET | Grenoble | 38043 | France |
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| Label | URL |
|---|---|
| FILO internet site | View source |
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| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| INDUSTRY |
| Chugai Pharma Europe Ltd. | INDUSTRY |
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Residual disease evaluated by molecular biology on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells |
| 6 years |
| Intermediate response predictive factors study | Predictive factors are determined at diagnosis are watched at Intermediate response | 4 months |
| Toxicity of RiBVD regimen according to NCI criteria Hematological and non-hematological toxicity | Toxicities are collected at every course = every 28 days during 6 months | 6 months |
| Prognosis value on Overall survival and progression free survival and on duration of response, of the MIPI index, MIPIb index and goelams index | 36 months |
| Residual disease evaluated by molecular biology Q-PCR on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells | blood and bone marrow samples sent to central laboratory for molecular residual disease at diagnosis, treatment evaluation and follow-up | 42 months |
| Diagnostic PET scan results, at intermediate and final analysis | Pet scan results at intermediate analysis = 4 months Pet scan results at final analysis = 6 months | 4 and 6 months |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |