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

NCT05678933 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-01-10

No results posted yet for this study

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.

Conditions

  • Peripheral T-cell Lymphoma Targeted Therapy

Interventions

DRUG

Azacitidine

Azacitidine (75mg/ m2) will be administered at day 1-5 by subcutaneous injection of each 21-day cycle.

DRUG

Chidamide

Chidamide (20 mg) will be taken orally twice a week for two weeks of each 21-day cycle.

DRUG

Cyclophosphamide

Cyclophosphamide (750 mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

DRUG

Epirubicin

Epirubicin (70mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

DRUG

Vincristine

Vincristine (1.4mg/ m2，Max dose 2mg) will be administered by an intravenous injection on day 1of each 21-day cycle.

DRUG

Prednisone

Prednisone (100 mg) will be taken orally from day 1-5 of each 21-day cycle.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2027-12-01
Completion
2029-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05678933 on ClinicalTrials.gov