Combining Tucidinostat and Azacitidine with CHOP for untreated Peripheral T-cell Lymphoma

A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma

This study is testing a new combination of treatments for people with untreated peripheral T-cell lymphoma to see if it works better than the standard chemotherapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 107 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05075460 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial evaluates the effectiveness and safety of a combination treatment involving Tucidinostat, Azacitidine, and the CHOP regimen compared to the standard CHOP regimen in patients with untreated peripheral T-cell lymphoma. Tucidinostat is a histone deacetylase inhibitor, while Azacitidine is a hypomethylating agent, both of which aim to enhance the therapeutic effects of the CHOP chemotherapy. The study is multicenter and prospective, focusing on patients aged 18 to 70 with confirmed diagnoses of peripheral T-cell lymphoma.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with confirmed peripheral T-cell lymphoma and adequate organ and bone marrow function.

Not a fit: Patients with ALK positive anaplastic T-cell lymphoma or those with uncontrolled infections or significant cardiac issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could offer a more effective option for patients with untreated peripheral T-cell lymphoma.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing treatment outcomes for lymphoma patients.

Eligibility criteria

Inclusion Criteria:

* Patients with peripheral T-cell lymphoma confirmed by primary pathology;
* Age 18-70 years;
* ECOG performance status ≤ 2;
* Adequate bone marrow hematopoietic function: WBC \> 3.5 × 10\*9/L，ANC\>1.5 × 10\*9/L，HGB\>90g/L，PLT\>80 × 10\*9/L;
* Adequate organ function: cardiac function grade 0-2 (NYHA); SpO2 \> 88% (natural condition); ALT\<3UNL，TBil\<2ULN; SCr\>60ml/min/m2;
* Patients have signed the Informed Consent Form

Exclusion Criteria:

* ALK positive anaplastic T-cell lymphoma;
* NK / T cell lymphoma, nasal type;
* Uncontrolled active infection;
* Acute myocardial infarction or unstable angina pectoris within 6 months; uncontrolled hypertension, symptomatic arrhythmia, etc;
* Subjects who are known or suspected to be unable to comply with the study protocol;
* Pregnant or lactating women

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Yan Zhang

Conditions: T-cell Lymphoma, Tucidinostat, Azacitidine, CHOP