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

High Grade Lymphomas CD20 Positive Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958996
• Other study ID #: OROCIEP
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 7, 2013
• Last updated: October 10, 2017
• Start date: January 2009
• Est. completion date: December 31, 2016

Study information

• Verified date: October 2017
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Grade Lymphomas CD20 Positive
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• idarubicin

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of idarubicin		9 months
Secondary	Remission rate after 4 cycles and 8 cycles		9 months