| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | A Phase II Study of Rituximab Combined With CHOP in T-Cell Angio-Immunoblastic Lymphoma | ||||||||
| Official Title † | Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-Cell Angioimmunoblastic Lymphoma (AIL). | ||||||||
| Brief Summary | 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. |
||||||||
| Detailed Description | 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. |
||||||||
| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Overall Response Rate (ORR) [Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment. | ||||||||
| Secondary Outcome Measure † | - Event-free survival (EFS) at 2 years: events being death from any cause, relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment. - Overall survival (OS), time to progression (TTF) and disease-free survival (DFS). - Safety of R-CHOP in this patient's population. - Correlation between response rate, survival and biological informations (phenotype, EBV status, T/B clonality). - Biological studies. |
||||||||
| Condition † | Untreated T-Cell Angioimmunoblastic Lymphoma | ||||||||
| Intervention † | Drug: Rituximab + CHOP regimen | ||||||||
| MEDLINE PMIDs | 11781247, 12357368, 11888076, 9639502 | ||||||||
| Links | Official site of the Groupe d'Etude des Lymphomes de l'Adulte (In french)  |
||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Active, not recruiting | ||||||||
| Enrollment † | 25 | ||||||||
| Start Date † | September 2005 | ||||||||
| Completion Date | December 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | France | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00169156 | ||||||||
| Organization ID | RAIL | ||||||||
| Secondary IDs †† | EUDRACT Number: 2005-002602-37 | ||||||||
| Study Sponsor † | Groupe d'Etudes de Lymphomes de L'Adulte | ||||||||
| Collaborators †† | Hoffmann-La Roche | ||||||||
| Investigators † |
|
||||||||
| Information Provided By | Groupe d'Etudes de Lymphomes de L'Adulte | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | September 12, 2005 | ||||||||
| Last Updated Date | May 29, 2008 | ||||||||
|
