drugset / Trial / 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

NCT01958996

Phase 1/2 Completed 27 enrolled Poitiers University Hospital
NaSingle-groupTreatment

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.

Timeline

Start
2009-01
Primary completion
2016-12-31
Completion
2016-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Idarubicin Small molecule Oral