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| Name | Class |
|---|---|
| Lymphoma Study Association | OTHER |
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Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.
Demonstration of the superiority in terms of 4-year event-free survival (EFS) of Rituximab maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years inclusive, treated with R-DHAP then autologous transplantation for MCL as first-line therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | observation : 3 years maintenance period with assesments and surveillance every 2 months |
|
| 2 | Experimental | maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| event-free survival (EFS) post Rituximab maintenance therapy | EFS post 4 years after maintenance |
| Measure | Description | Time Frame |
|---|---|---|
| duration of PFS of the entire group of patients. | Safety/efficacy of maintenance treatment | |
| duration of OS of the entire group of patients | safety/efficacy of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven LE GOUILL, MD | French Innovative Leukemia Organisation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional University Hospital | Nantes | 44093 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38669626 | Derived | Sarkozy C, Callanan M, Thieblemont C, Oberic L, Burroni B, Bouabdallah K, Damaj G, Tessoulin B, Ribrag V, Houot R, Morschhauser F, Griolet S, Joubert C, Cacheux V, Delwail V, Safar V, Gressin R, Cheminant M, Delfau-Larue MH, Hermine O, Macintyre E, Le Gouill S. Obinutuzumab vs rituximab for transplant-eligible patients with mantle cell lymphoma. Blood. 2024 Jul 18;144(3):262-271. doi: 10.1182/blood.2024023944. | |
| 28953447 |
| Label | URL |
|---|---|
| FILO Website | 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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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D019370 | Observation |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Watch and wait | Other | No treatment patient follow-up every 2 months during 3 years |
|
|
| complete, partial and overall response rate after induction with R-DHAP and after ASCT. |
| safety/efficacy of all the treatment |
| Derived |
| Le Gouill S, Thieblemont C, Oberic L, Moreau A, Bouabdallah K, Dartigeas C, Damaj G, Gastinne T, Ribrag V, Feugier P, Casasnovas O, Zerazhi H, Haioun C, Maisonneuve H, Houot R, Jardin F, Van Den Neste E, Tournilhac O, Le Du K, Morschhauser F, Cartron G, Fornecker LM, Canioni D, Callanan M, Bene MC, Salles G, Tilly H, Lamy T, Gressin R, Hermine O; LYSA Group. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017 Sep 28;377(13):1250-1260. doi: 10.1056/NEJMoa1701769. |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008722 | Methods |
| D008919 | Investigative Techniques |