Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Lymphomas CD20 Positive | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- idarubicin
- interventionNames
- Drug: idarubicin
Primary outcomes (1)
- measure
- Maximum tolerated dose of idarubicin
- timeFrame
- 9 months
Secondary outcomes (1)
- measure
- Remission rate after 4 cycles and 8 cycles
- timeFrame
- 9 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGuidez S, Lacotte-Thierry L, Tomowiak C, Princet I, Dreyfus B, Olivier G, Fleck E, Corby A, Motard C, Barrier J, Machet A, Le Du K, Debiais-Delpech C, Chabin M, Leleu X, Guilhot J, Delwail V. Oral CHOP-like chemotherapy in 60-80 years-old patients with diffuse large B-cell lymphoma. Br J Haematol. 2019 Sep;186(6):e175-e178. doi: 10.1111/bjh.16056. Epub 2019 Jul 15. No abstract available. PMID 31309541