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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).
Study ID: NCT00169156
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hôpital Henri Mondor, Créteil, , France
Hôpital Saint Louis, Paris, , France
Service d'Hématologie - Centre Hospitalier Lyon-Sud, Pierre-Bénite cedex, , France
Centre Henri Becquerel, Rouen, , France
Name: Corinne Haioun, MD
Affiliation: Hôpital Henri Mondor, Créteil, France
Role: STUDY_CHAIR
Name: Bertrand Joly, MD
Affiliation: C.H. Sud Francilien, Corbeil-Essonnes, France
Role: PRINCIPAL_INVESTIGATOR