This trial is active, not recruiting.

Condition high grade lymphomas cd20 +
Treatment idarubicin
Phase phase 1/phase 2
Sponsor Poitiers University Hospital
Start date January 2009
End date December 2016
Trial size 27 participants
Trial identifier NCT01958996, OROCIEP


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Primary purpose treatment

Primary Outcomes

Maximum tolerated dose of idarubicin
time frame: 9 months

Secondary Outcomes

Remission rate after 4 cycles and 8 cycles
time frame: 9 months

Eligibility Criteria

Male or female participants from 65 years up to 80 years old.

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 information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Poitiers University Hospital.