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OpenTrials
Completed

NCT Number: NCT01958996

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

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.

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Key information

Conditions

High Grade Lymphomas CD20 Positive

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CHU de Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Idarubicin

Drug

Primary outcomes

  1. Maximum tolerated dose of idarubicin

    Time frame: 9 months

Secondary outcomes

  1. Remission rate after 4 cycles and 8 cycles

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Oct 9, 2013
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.