By InvitationPhase 3

AC-CHOP Versus CHOP in Patients With Previously Untreated PTCL-TFH

China200 participantsStarted 2023-01-01

Plain-language summary

This study is an open label, multicenter study. Subjects are randomized at a 1:1 ratio to receive either (arm A) azacitidine administered IH at day 1-5 and chidamide admistered twice a week for two weeks in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) or (arm B) CHOP administered every 3 weeks for 6 cycles in patients with previously untreated peripheral T-cell lymphoma.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
✓. Males and females of 18 years of age to 70 years of age.
✓. ECOG performance status 0, 1 or 2
✓. Patients with histologically proven peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH); the following subtypes as defined by the WHO classification (5th) may be included, whatever the Ann Arbor stage (I - IV):
✓. Previously received no treatment for PTCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except for relieving tumor-related symptoms), surgical treatment (except for tumor or pathological tissue biopsy)
✓. Life expectancy of ≥ 90 days (3 months)
✓. At least one evaluable or measurable lesion that meets Lugano2014 criteria: lymph node lesions, which are measurable \> 1.5 cm, and non-lymph node lesions, which are measurable\>1.0 cm
✓. Female and males patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 12 month thereafter

Exclusion criteria

✕. Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before randomization
✕. Contraindication to any drug contained in the chemotherapy regimen

What they're measuring

Progression-free survival (PFS)

Timeframe: Up to 1 year

Trial details

NCT IDNCT05678933

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

View on ClinicalTrials.gov More Peripheral T-cell Lymphoma Targeted Therapy trials