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Study of Entospletinib (ENTO) in Newly Diagnosed DLBCL Patients With aaIPI>=1 Treated by Chemiotherapy

NCT03225924 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-09-02

No results posted yet for this study

Summary

The primary objective of the phase Ib of the study is to determine the recommended phase 2 dose (RP2D) for entospletinib (ENTO) in patients treated with R-CHOP.

The primary objective of the phase II is to determine the complete metabolic response (CMR) rate by the Lugano classification 2014 (Deauville scale 1-3) at the end of treatment.

Conditions

Interventions

DRUG

Entospletinib

200mg or 400mg twice a day for 7 days every 21 cycles - total of 8 cycles

DRUG

Rituximab

cycles of 21 days - 375mg/m²

DRUG

Cyclophosphamide

cycles of 21 days - 750 mg/m²

DRUG

Doxorubicin

cycles of 21 days - 50mg/m²

DRUG

Vincristine

cycles of 21 days - 1.4mg/m²

DRUG

Prednisone

cycles of 21 days - 40mg/m²

Sponsors & Collaborators

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Gilles Salles · Hospices Civils de Lyon

  • Emmanuelle Tchernonog · University Hospital, Montpellier

  • Julien Depaus · UCL Namur

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2019-10-18
Completion
2019-10-18

Countries

  • Belgium
  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03225924 on ClinicalTrials.gov