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
Primary Purpose
High Grade Lymphomas CD20 Positive
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
idarubicin
Sponsored by
About this trial
This is an interventional treatment trial for High Grade Lymphomas CD20 Positive
Eligibility Criteria
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.
Sites / Locations
- CHU de Poitiers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
idarubicin
Arm Description
Outcomes
Primary Outcome Measures
Maximum tolerated dose of idarubicin
Secondary Outcome Measures
Remission rate after 4 cycles and 8 cycles
Full Information
NCT ID
NCT01958996
First Posted
October 7, 2013
Last Updated
October 10, 2017
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01958996
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
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: " 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Grade Lymphomas CD20 Positive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
idarubicin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
idarubicin
Primary Outcome Measure Information:
Title
Maximum tolerated dose of idarubicin
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Remission rate after 4 cycles and 8 cycles
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31309541
Citation
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.
Results Reference
derived
Learn more about this trial
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
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