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Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma

RECRUITINGPhase 3Sponsored by Peking Union Medical College Hospital
Actively Recruiting
PhasePhase 3
SponsorPeking Union Medical College Hospital
Started2021-10-01
Est. completion2024-05-30
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

Summary

This is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions2

CancerT - Cell Lymphoma

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