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

Poitiers University Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: High Grade Lymphomas CD20 Positive

Treatments: Drug: idarubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT01958996

OROCIEP

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

27 participants in 1 patient group

idarubicin

Experimental group

Treatment:

Drug: idarubicin