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
NCT ID: NCT01958996
Last Updated: 2017-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2009-01-31
2016-12-31
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
Study Groups
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idarubicin
idarubicin
Interventions
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idarubicin
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Age \> 65 and \< 80 years
* Performance status (ECOG) \<3
* measurable disease
* Serology HIV negative, Hepatites B, Hepatites C negative
Exclusion Criteria
* Cardiac failure.
65 Years
80 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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CHU de Poitiers
Poitiers, , France
Countries
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References
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Guidez 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.
Other Identifiers
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OROCIEP
Identifier Type: -
Identifier Source: org_study_id