NCT01958996

Phase I/II Study of Escalating Doses of Idarubicin Orally Given With Oral Cyclophosphamide, Etoposide, Prednisolone and Intravenous Rituximab in Elderly Patient With Disseminated High Grade Non Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

R-CHOP with doxorubicin is the standard first line treatment of high grade non-Hodgkin's lymphoma. In order to avoid central venous system insertion and reduce hospitalization time in elderly patients, we developed an oral chemotherapy treatment: " OROCIEP"trial. Nineteen patients were enrolled and 127 chemotherapy cycles were available for toxicities. The estimated two-years overall survival was 74%. The main haematological toxicity was neutropenia. This study is still ongoing to confirm recommended dose of oral anthracycline.

Conditions

• High Grade Lymphomas CD20 Positive

Interventions

Type	Name	Description
DRUG	idarubicin

Timeline

• Start date: 2009-01-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2013-10-09
• Last updated: 2017-10-11

Locations

1 site across 1 country: France