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
• Trial end date: 2016-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poitiers University Hospital
• Treatments: Idarubicin

Criteria

Inclusion Criteria:

• CD20-positive diffuse large B-cell lymphoma.WHO classification (55)

• Written informed consent

• Age > 65 and < 80 years

• Performance status (ECOG) <3

• measurable disease

• Serology HIV negative, Hepatites B, Hepatites C negative

Exclusion Criteria:

• Serology HIV positive, Hepatite B positive, Hepatite C positive

• Cardiac failure.