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

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT03225924
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Entospletinib — DRUG
    200mg or 400mg twice a day for 7 days every 21 cycles - total of 8 cycles
  • Rituximab — DRUG
    cycles of 21 days - 375mg/m²
  • Cyclophosphamide — DRUG
    cycles of 21 days - 750 mg/m²
  • Doxorubicin — DRUG
    cycles of 21 days - 50mg/m²
  • Vincristine — DRUG
    cycles of 21 days - 1.4mg/m²
  • Prednisone — DRUG
    cycles of 21 days - 40mg/m²

Study Details

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.

Key Dates

Start date
Jul 26, 2017
Status verified
Sep 2020
Primary completion
Oct 18, 2019
Completion
Oct 18, 2019

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Entospletinib + Rituximab + Cyclophosphamide + Doxorubicine + Vincristine + Prednisone

Primary Outcome Measure

Phase I: recommended phase 2 dose [ Time Frame: 6 months ]

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