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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01958996

Enrollment

Registered

2013-10-09

Start date

2009-01-31

Completion date

2016-12-31

Last updated

2017-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Grade Lymphomas CD20 Positive

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: OROCIEPtrial. 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.

Interventions

DRUGidarubicin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

65 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose of idarubicin	9 months

Secondary

Measure	Time frame
Remission rate after 4 cycles and 8 cycles	9 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026