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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
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Grade Lymphomas CD20 Positive

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept 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.

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

First Posted
October 7, 2013
Last Updated
October 10, 2017
Sponsor
Poitiers University Hospital
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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

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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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