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A multi-center prospective single-arm clinical trial of azacitidine and chidamide combined with CHOP regimen (AC-CHOP) in patients with de-novo PTCL with TFH phenotype

A multi-center prospective single-arm clinical trial of azacitidine and chidamide combined with CHOP(cyclophosphamide, doxorubicin, vincristine and prednisone) regimen (AC-CHOP) in patients with de-novo peripheral T-cell lymphoma (PTCL) with follicular T-helper (TFH) phenotype

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047467
Enrollment
Unknown
Registered
2021-06-19
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTCL with TFH phenotype

Interventions

Experimental group:AC-CHOP regimen

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. De-novo PTCL with TFH phenotype, including AITL, FTH lymphoma and nodal PTCL with TFH phenotype, which are confirmed by pathology study; 2. Aged 18 to 75 years; 3. ECOG score <= 3; 4. Informed consent has been signed prior to carrying out any particular research operation; 5. Expected survival is at least 3 months, as determined by the investigator; 6. For men or women of reproductive age who have not undergone sterilization, consent to effective contraception during the treatment period and 12 months after the last study drug use is administered.

Exclusion criteria

Exclusion criteria: 1. Patients have receive and systemic or tropical chemotherapy except for corticosteroid prior to inclusion; 2. History or evidence of other malignant tumor; 3. Hisotry or evidence of CNS lymphoma infiltration; 4. Major surgical procedures were performed within 14 days of treatment of DLBCL; 5. Severe and uncontrolled cardiovascular disease; 6. Neutrophils 2 fold ULN); 8. Hepatic function abnormality (total bilirubin level > 2 fold ULN, transaminases> 3 fold ULN) unless these abnormalities are related to the lymphoma; 9. Uncontrolled and active systemic fungi, bacteria, viruses or other infections; 10. HIV infection; 11. Uncontrolled and active HBV and HCV infection; 12. Any situation that investigator found it inappropriate to join this trial.

Design outcomes

Primary

MeasureTime frame
complete remission rate;

Secondary

MeasureTime frame
objective response rate;Progression Free Survival;overall survival;Quality of Life;

Countries

China

Contacts

Public ContactNiu Ting

West China Hospital, Sichuan University

tingniu@sina.com+86 18980601247

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026