|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Groupe d'Etudes de Lymphomes de L'Adulte Hoffmann-La Roche |
| Information provided by: | Groupe d'Etudes de Lymphomes de L'Adulte |
| ClinicalTrials.gov Identifier: | NCT00169156 |
Purpose
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.
| Condition | Intervention | Phase |
|
Untreated T-Cell Angioimmunoblastic Lymphoma |
Drug: Rituximab + CHOP regimen |
Phase II |
| MedlinePlus related topics: | Lymphoma |
| ChemIDplus related topics: | Rituximab |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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). |
| Estimated Enrollment: | 25 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | December 2009 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |||||
| Hôpital Henri Mondor | |||||
| Créteil, France | |||||
| Hôpital Saint Louis | |||||
| Paris, France | |||||
| Centre Henri Becquerel | |||||
| Rouen, France | |||||
| Service d'Hématologie - Centre Hospitalier Lyon-Sud | |||||
| Pierre-Bénite cedex, France, 69495 | |||||
| Groupe d'Etudes de Lymphomes de L'Adulte |
| Hoffmann-La Roche |
| Study Chair: | Corinne Haioun, MD | Hôpital Henri Mondor, Créteil, France |
| Principal Investigator: | Bertrand Joly, MD | C.H. Sud Francilien, Corbeil-Essonnes, France |
More Information
Official site of the Groupe d'Etude des Lymphomes de l'Adulte (In french) 
  |
| Study ID Numbers: | RAIL, EUDRACT Number: 2005-002602-37 |
| First Received: | September 12, 2005 |
| Last Updated: | May 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00169156 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
|
|
|
|