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

Phase 2CompletedNCT01958996

Poitiers University Hospital27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Enrollment

Conditions

High Grade Lymphomas CD20 Positive

Interventions

idarubicinDRUG

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Maximum tolerated dose of idarubicin

Time frame: 9 months

Secondary Outcomes

Remission rate after 4 cycles and 8 cycles