NCT00169156

A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma

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).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Untreated T-cell Angioimmunoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	375 mg/m2 D1
DRUG	Prednisone	40 mg/m2 D1 to D5
DRUG	Doxorubicine	50 mg/m2 D1
DRUG	Cyclophosphamide	750 mg/m2 D1
DRUG	Vincristine	1,4 mg/m2 D1

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-12-01
• Completion: 2012-11-01
• First posted: 2005-09-15
• Last updated: 2017-03-13

Locations

4 sites across 1 country: France