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

Primary Purpose

Peripheral T-cell Lymphoma Targeted Therapy

Status
Enrolling by invitation
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Azacitidine
Chidamide
Cyclophosphamide
Epirubicin
Vincristine
Prednisone
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma Targeted Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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) 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. Other situations that investigators considered inappropriate for enrollment

Sites / Locations

  • Tianjin Medical University Cancer Insititute & Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AC-CHOP

CHOP

Arm Description

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)

CHOP administered every 3 weeks for 6 cycles.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

Full Information

First Posted
December 28, 2022
Last Updated
January 9, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05678933
Brief Title
AC-CHOP Versus CHOP in Patients With Previously Untreated PTCL-TFH
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2027 (Anticipated)
Study Completion Date
December 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma Targeted Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AC-CHOP
Arm Type
Experimental
Arm Description
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)
Arm Title
CHOP
Arm Type
Active Comparator
Arm Description
CHOP administered every 3 weeks for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Azacitidine (75mg/ m2) will be administered at day 1-5 by subcutaneous injection of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
Chidamide (20 mg) will be taken orally twice a week for two weeks of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide (750 mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
Epirubicin (70mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine (1.4mg/ m2,Max dose 2mg) will be administered by an intravenous injection on day 1of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone (100 mg) will be taken orally from day 1-5 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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) 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. Other situations that investigators considered inappropriate for enrollment
Facility Information:
Facility Name
Tianjin Medical University Cancer Insititute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China

12. IPD Sharing Statement

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

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