Peripheral T-cell Lymphoma Targeted TherapyPhase 3NCT05678933
AC-CHOP Versus CHOP in Patients With Previously Untreated PTCL-TFH
A Phase 3 study testing Azacitidine, Chidamide and Cyclophosphamide in people with Peripheral T-cell Lymphoma Targeted Therapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral T-cell Lymphoma Targeted Therapy
- What is being tested?
- Azacitidine, Chidamide and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Insititute & Hospital
Tianjin, Tianjin Municipality, 300060
About this study
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)
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.
- Being tested
- Azacitidine, Chidamide, Cyclophosphamide, Epirubicin, Vincristine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Azacitidine (75mg/ m2) will be administered at day 1-5 by subcutaneous injection of each 21-day cycle.
ChidamideDrug
Chidamide (20 mg) will be taken orally twice a week for two weeks of each 21-day cycle.
CyclophosphamideDrug
Cyclophosphamide (750 mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
EpirubicinDrug
Epirubicin (70mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
VincristineDrug
Vincristine (1.4mg/ m2，Max dose 2mg) will be administered by an intravenous injection on day 1of each 21-day cycle.
PrednisoneDrug
Prednisone (100 mg) will be taken orally from day 1-5 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Azacitidine; Drug: Chidamide; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone |
| CHOP | Active comparator | CHOP administered every 3 weeks for 6 cycles. Receives: Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Jan 2023 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell Lymphoma Targeted TherapyStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huilai Zhang, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678933
- Sponsor's protocol ID
- AC-CHOP Study
- Status last verified
- Dec 2022
- First submitted
- 28 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05678933
- Acronym / sponsor ID
- AC-CHOP Study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC-CHOP | Experimental | Drug: Azacitidine, Drug: Chidamide, Drug: Cyclophosphamide, Drug: Epirubicin, Drug: Vincristine, Drug: PrednisoneAzacitidine 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 | Active comparator | Drug: Cyclophosphamide, Drug: Epirubicin, Drug: Vincristine, Drug: PrednisoneCHOP administered every 3 weeks for 6 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacitidineAzacitidine (75mg/ m2) will be administered at day 1-5 by subcutaneous injection of each 21-day cycle. | Drug | AC-CHOP |
| ChidamideChidamide (20 mg) will be taken orally twice a week for two weeks of each 21-day cycle. | Drug | AC-CHOP |
| CyclophosphamideCyclophosphamide (750 mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. | Drug | AC-CHOP, CHOP |
| EpirubicinEpirubicin (70mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. | Drug | AC-CHOP, CHOP |
| VincristineVincristine (1.4mg/ m2，Max dose 2mg) will be administered by an intravenous injection on day 1of each 21-day cycle. | Drug | AC-CHOP, CHOP |
| PrednisonePrednisone (100 mg) will be taken orally from day 1-5 of each 21-day cycle. | Drug | AC-CHOP, CHOP |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azacitidine, Chidamide and Cyclophosphamide in people with Peripheral T-cell Lymphoma Targeted Therapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.