NCT01958996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

8 years

First QC Date

October 7, 2013

Last Update Submit

October 10, 2017

Conditions

High Grade Lymphomas CD20 Positive

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of idarubicin

    9 months

Secondary Outcomes (1)

  • Remission rate after 4 cycles and 8 cycles

    9 months

Study Arms (1)

idarubicin

EXPERIMENTAL
Drug: idarubicin

Interventions

idarubicinDRUG
idarubicin

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Serology HIV positive, Hepatite B positive, Hepatite C positive
  • Cardiac failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Poitiers

Poitiers, 86000, France

Location

Related Publications (1)

  • 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.

    PMID: 31309541DERIVED

MeSH Terms

Interventions

Idarubicin

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

January 1, 2009

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations

FR(1)