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OncoMatch/Clinical Trials/NCT06947967

Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype

Is NCT06947967 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) and Tucidinostat for lymphoma, t-cell, peripheral.

Phase 3RecruitingChipscreen Biosciences, Ltd.NCT06947967Data as of May 2026

Treatment: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) · TucidinostatA Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell Phenotype

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: lymphoma-targeted therapy

Received prior therapies targeting lymphoma

Cannot have received: cytotoxic drugs for another condition

Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis)

Cannot have received: investigational therapy

Any investigational therapy within 3 months

Lab requirements

Blood counts

Hemoglobin (Hb)≥90g/L, ANC ≥1.5×10^9/L, platelets ≥90×10^9/L

Kidney function

Serum creatinine ≤1.5×ULN

Liver function

Total bilirubin ≤1.5 × ULN, ALT/AST ≤2.5×ULN (ALT, AST≦5×ULN if liver involved)

Cardiac function

LVEF < 50% during screening, Grade II or higher congestive heart failure, unstable angina, MI within 6 months, arrhythmia requiring treatment, primary cardiomyopathy, history of significant QT interval prolongation, QTc≥450ms (male), QTc≥470ms (female), symptomatic coronary heart disease requiring treatment

Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry): (1)Hematology values:Hemoglobin (Hb)≥90g/L,Absolute neutrophil count (ANC) ≥1.5×10 9/L, platelets ≥90×10 9/L (2)Biochemical values: Serum creatinine ≤1.5×upper limit of normal(ULN),Total bilirubin ≤1.5 × ULN, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤2.5×ULN(ALT, AST≦5×ULN if liver involved). Cardiac: see exclusion criteria for details.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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