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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002602-37 | EudraCT Number |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.
This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.
It is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis performed every 5 patients (based on triangular test).
The duration of the treatment period is approximately 25 weeks and patients are followed until Death.
The total Duration of the study is expected to be 2.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab + CHOP | Experimental | Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 375 mg/m2 D1 |
| |
| Prednisone |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | [Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment. | 8 months (4 cycles of treatment + 4 cycles of consolidation) |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment. | Events being death from any cause | 2 years |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinne Haioun, MD | Hôpital Henri Mondor, Créteil, France | Study Chair |
| Bertrand Joly, MD | C.H. Sud Francilien, Corbeil-Essonnes, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor | Créteil | France | ||||
| HĂ´pital Saint Louis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11781247 | Background | Attygalle A, Al-Jehani R, Diss TC, Munson P, Liu H, Du MQ, Isaacson PG, Dogan A. Neoplastic T cells in angioimmunoblastic T-cell lymphoma express CD10. Blood. 2002 Jan 15;99(2):627-33. doi: 10.1182/blood.v99.2.627. | |
| 12357368 | Background | Lome-Maldonado C, Canioni D, Hermine O, Delabesse E, Damotte D, Raffoux E, Gaulard P, Macintyre E, Brousse N; French Groupe d'Etude des Lymphomes de l'Adulte (GELA). Angio-immunoblastic T cell lymphoma (AILD-TL) rich in large B cells and associated with Epstein-Barr virus infection. A different subtype of AILD-TL? Leukemia. 2002 Oct;16(10):2134-41. doi: 10.1038/sj.leu.2402642. |
| Label | URL |
|---|---|
| Official site of the Groupe d'Etude des Lymphomes de l'Adulte (In french) | View source |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D011241 | Prednisone |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
40 mg/m2 D1 to D5 |
|
| Doxorubicine | Drug | 50 mg/m2 D1 |
|
| Cyclophosphamide | Drug | 750 mg/m2 D1 |
|
| Vincristine | Drug | 1,4 mg/m2 D1 |
|
| 2 years |
| Time to progression (TTF) | 2 years |
| Disease-free survival (DFS). | 2 years |
| number of SAE | 2 years |
| Paris |
| France |
| Service d'Hématologie - Centre Hospitalier Lyon-Sud | Pierre-Bénite | 69495 | France |
| Centre Henri Becquerel | Rouen | France |
| 11888076 | Background | Zettl A, Lee SS, Rudiger T, Starostik P, Marino M, Kirchner T, Ott M, Muller-Hermelink HK, Ott G. Epstein-Barr virus-associated B-cell lymphoproliferative disorders in angloimmunoblastic T-cell lymphoma and peripheral T-cell lymphoma, unspecified. Am J Clin Pathol. 2002 Mar;117(3):368-79. doi: 10.1309/6UTX-GVC0-12ND-JJEU. |
| 9639502 | Background | Gisselbrecht C, Gaulard P, Lepage E, Coiffier B, Briere J, Haioun C, Cazals-Hatem D, Bosly A, Xerri L, Tilly H, Berger F, Bouhabdallah R, Diebold J. Prognostic significance of T-cell phenotype in aggressive non-Hodgkin's lymphomas. Groupe d'Etudes des Lymphomes de l'Adulte (GELA). Blood. 1998 Jul 1;92(1):76-82. |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |