Phase III Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed Double-Expressor DLBCL

Sponsor
Chipscreen Biosciences, Ltd.
Study ID
NCT04231448
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) — DRUG
    R-CHOP : rituximab 375 mg/m2 IV, cyclophosphamide 750 mg/m2 IV, doxorubicin 50 mg/m2 IV, vincristine 1.4 mg/m2 IV \[maximum total 2 mg\], and prednisone \[or equivalent\] 100 mg orally as the background therapy for 6 cycles (21 days/cycle).
  • Tucidinostat — DRUG
    Tucidinostat ：30 mg was given orally after breakfast on day 1, day 4, day 8, day 11 in a 21-day cycle，for 6 cycles. After cycle 6 patients who are evaluated as complete response will receive 24 weeks additional administrations of Tucidinostat on day 1, day 4, day 8, day 11 in a 21-day cycle.
  • Placebo — DRUG
    Placebo：30 mg was given orally after breakfast on day 1, day 4, day 8, day 11 in a 21-day cycle，for 6 cycles. After cycle 6 patients who are evaluated as complete response will receive 24 weeks additional administrations of placebo on day 1, day 4, day 8, day 11 in a 21-day cycle.

Study Details

Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. This Randomized, Double-blind, Placebo-controlled Phase 3 trail is studying the efficacy and safety of Tucidinostat, in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed MYC/BCL2 Double-Expressor Diffuse Large B-cell Lymphoma.

Key Dates

Start date
May 21, 2020
Status verified
Apr 2026
Primary completion
Jan 10, 2023
Completion
Jun 29, 2025

Study Design

Enrollment
423 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CR-CHOP
  • Placebo Comparator: R-CHOP

Primary Outcome Measure

Event Free Survival (EFS) [ Time Frame: Up to approximately 5 years ]

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