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

January 9, 2023 updated by: Huilai Zhang, Tianjin Medical University Cancer Institute and Hospital

Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Azacitidine and Chidamide Combined With CHOP (AC-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma With T-follicular Helper Phenotype (PTCL-TFH)

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Medical University Cancer Insititute & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients must satisfy all following criteria to be enrolled in the study:

  1. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
  2. Males and females of 18 years of age to 70 years of age.
  3. ECOG performance status 0, 1 or 2

  4. 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):

    i.Angioimmunoblastic T-cell lymphoma ii. peripheral T-cell lymphoma of follicular type iii. Nodal and extra-nodal peripheral T cell lymphoma with follicular helper T cell phenotype

  5. 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)
  6. Life expectancy of ≥ 90 days (3 months)
  7. 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
  8. 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
  9. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelet count ≥ 80 x 109/L, Haemoglobin ≥ 90g/L
  10. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) , AST or ALT ≤ 2.5 x ULN (≤ 5 x ULN for liver involvement), serum total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for liver involvement)
  11. Able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

Presence of any of the following will exclude a patient from enrollment:

  1. Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before randomization
  2. Contraindication to any drug contained in the chemotherapy regimen
  3. Previous or current malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast have been effectively controlled) unless the patient has been free of the disease for ≥ 5 years
  4. Primary or secondary central nervous system (CNS) lymphoma involvement or having a history of CNS lymphoma at the time of recruitment
  5. Undergone major surgical procedures within 14 days prior to the first dose of study drug
  6. Significant and uncontrolled cardiovascular disease at screening

  7. Any of the following laboratory abnormalities, except if secondary to the lymphoma:

    1. Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 x 109/L),
    2. Platelet count < 50,000/mm3 (50 x 109/L)
    3. Serum total bilirubin > 2 x ULN, serum ALT or AST > 3.0 x upper limit of normal (ULN), except if investigator believes that the abnormal liver function is caused by the disease
    4. Serum creatinine > 2.0 x ULN, except if investigator believes that the abnormal liver function is caused by the disease
  8. Uncontrolled active systemic fungal, bacterial, viral or other infections
  9. Subjects with HIV positivity
  10. Subjects with active hepatitis B or C (HBs Ag+/HBc Ab+ and HBV DNA>1x103copy/mL; HCV DNA>1x103copy/mL)
  11. Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study.
  12. Other situations that investigators considered inappropriate for enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AC-CHOP
Azacitidine administered IV at day 1-5 and Chidamide admistered twice a week for two weeks in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)
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.
Active Comparator: CHOP
CHOP administered every 3 weeks for 6 cycles.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

December 1, 2027

Study Completion (Anticipated)

December 1, 2029

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Estimate)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-CHOP Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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