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

NCT05678933 | Enrolling By Invitation Phase 3

• 1 other identifier: AC-CHOP Study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Up to 1 year

Study Arms (2)

AC-CHOP

EXPERIMENTAL

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; Drug: Chidamide; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone

CHOP

ACTIVE COMPARATOR

CHOP administered every 3 weeks for 6 cycles.

Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone

Interventions

Azacitidine DRUG

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

AC-CHOP

Chidamide DRUG

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

AC-CHOP

Cyclophosphamide DRUG

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

AC-CHOP; CHOP

Epirubicin DRUG

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

AC-CHOP; CHOP

Vincristine DRUG

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

AC-CHOP; CHOP

Prednisone DRUG

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

AC-CHOP; CHOP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must satisfy all following criteria to be enrolled in the study:
• 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):
• 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
• 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
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelet count ≥ 80 x 109/L, Haemoglobin ≥ 90g/L
• 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)
• Able to adhere to the study visit schedule and other protocol requirements.

You may not qualify if:

• Presence of any of the following will exclude a patient from enrollment:
• 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
• 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
• Primary or secondary central nervous system (CNS) lymphoma involvement or having a history of CNS lymphoma at the time of recruitment
• Undergone major surgical procedures within 14 days prior to the first dose of study drug
• Significant and uncontrolled cardiovascular disease at screening
• Any of the following laboratory abnormalities, except if secondary to the lymphoma:
• Absolute neutrophil count (ANC) \< 1,000 cells/mm3 (1.0 x 109/L),
• Platelet count \< 50,000/mm3 (50 x 109/L)
• 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
• Serum creatinine \> 2.0 x ULN, except if investigator believes that the abnormal liver function is caused by the disease
• Uncontrolled active systemic fungal, bacterial, viral or other infections
• Subjects with HIV positivity
• Subjects with active hepatitis B or C (HBs Ag+/HBc Ab+ and HBV DNA\>1x103copy/mL; HCV DNA\>1x103copy/mL)

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Insititute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Interventions

Azacitidine; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Cyclophosphamide; Epirubicin; Vincristine; Prednisone

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of department of lymohoma

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 10, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 10, 2023

Record last verified: 2022-12

Locations

CN (1)