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
- Registration Number
- NCT01958996
- Lead Sponsor
- Poitiers University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description idarubicin idarubicin -
- Primary Outcome Measures
Name Time Method Maximum tolerated dose of idarubicin 9 months
- Secondary Outcome Measures
Name Time Method Remission rate after 4 cycles and 8 cycles 9 months
Trial Locations
- Locations (1)
CHU de Poitiers
🇫🇷Poitiers, France
CHU de Poitiers🇫🇷Poitiers, France