T-cell LymphomaPhase 3NCT05075460
Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma
A Phase 3 study testing Tucidinostat, Azacitidine combined with CHOP in people with T-cell Lymphoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- T-cell Lymphoma
- What is being tested?
- Tucidinostat, Azacitidine combined with CHOP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 with peripheral T-cell lymphoma confirmed by primary pathology;
- Age 18-70 years;
- ECOG performance status ≤ 2;
- Adequate bone marrow hematopoietic function: WBC > 3.5 × 10*9/L，ANC>1.5 × 10*9/L，HGB>90g/L，PLT>80 × 10*9/L;
- Adequate organ function: cardiac function grade 0-2 (NYHA); SpO2 > 88% (natural condition); ALT<3UNL，TBil<2ULN; SCr>60ml/min/m2;
- Patients have signed the Informed Consent Form
Who cannot join
- ALK positive anaplastic T-cell lymphoma;
- NK / T cell lymphoma, nasal type;
- Uncontrolled active infection;
- Acute myocardial infarction or unstable angina pectoris within 6 months; uncontrolled hypertension, symptomatic arrhythmia, etc;
- Subjects who are known or suspected to be unable to comply with the study protocol;
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Daobin Zhou, Doctor
About this study
Official title: A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma
This is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma
Read the detailed description
Tucidinostat, a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. Azacytidine is a hypomethylating agent. The aim of this study is to compare the efficacy and safety of azacytidine, tucidinostat combined with CHOP regimen and classical CHOP regimen in the treatment of primary PTCL
- Conditions
- T-cell Lymphoma
- Being tested
- Tucidinostat, Azacitidine combined with CHOP
- Keywords
- Tucidinostat, Azacitidine, CHOP
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tucidinostat, Azacitidine combined with CHOPDrug
Azacitidine: 200 mg D1200 mg D2100 mg D3 subcutaneous injection Tucidinostat: 20mg / time, D1, 4, 8, 11; Take medicine with 200ml warm boiled water 30 minutes after breakfast.
CHOP chemotherapy:
- Cyclophosphamide (CTX) 750mg / m2 intravenous infusion, day 1;
- Epirubicin (EPI) 70mg / m2 intravenous infusion, day 1;
- Vinoresin (VDS) 4mg intravenous infusion, day 1;
- Prednisone 100mg orally, day 1-5. Every 21 days is a course of treatment
| Study group | Role | What they receive |
|---|---|---|
| Tucidinostat, Azacitidine combined with CHOP | Experimental | Tucidinostat, Azacitidine combined with CHOP Receives: Drug: Tucidinostat, Azacitidine combined with CHOP |
| CHOP | Active comparator | CHOP Receives: Drug: Tucidinostat, Azacitidine combined with CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
the total proportion of patients with complete response (CR) and partial response (PR)
Measured: 6 course of treatment (each cycle is 21 days)
Secondary outcomes (3)
2-year progression-free survival（PFS）
Time from treatment until disease progression or death
Measured: 2 years
2-year overall survival（OS）
Time from treatment until death from any cause
Measured: 2 years
Incidence and severity of adverse events, serious adverse events and other safety parameters
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Oct 2021
- Primary completion30 May 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Zhang, MD, Peking Union Medical College Hospital
- Investigators
- Daobin Zhou, Study chair, Department of Hematology, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075460
- Sponsor's protocol ID
- PUMCH-NHL-010
- Status last verified
- Apr 2024
- First submitted
- 22 Sep 2021
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05075460
- Acronym / sponsor ID
- PUMCH-NHL-010
- Conditions
- T-cell Lymphoma
- Keywords
- Tucidinostat, Azacitidine, CHOP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 12 Oct 2021 (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 is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma
Detailed description
Tucidinostat, a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. Azacytidine is a hypomethylating agent. The aim of this study is to compare the efficacy and safety of azacytidine, tucidinostat combined with CHOP regimen and classical CHOP regimen in the treatment of primary PTCL
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tucidinostat, Azacitidine combined with CHOP | Experimental | Drug: Tucidinostat, Azacitidine combined with CHOPTucidinostat, Azacitidine combined with CHOP |
| CHOP | Active comparator | Drug: Tucidinostat, Azacitidine combined with CHOPCHOP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with peripheral T-cell lymphoma confirmed by primary pathology;
- Age 18-70 years;
- ECOG performance status ≤ 2;
- Adequate bone marrow hematopoietic function: WBC > 3.5 × 10*9/L，ANC>1.5 × 10*9/L，HGB>90g/L，PLT>80 × 10*9/L;
- Adequate organ function: cardiac function grade 0-2 (NYHA); SpO2 > 88% (natural condition); ALT<3UNL，TBil<2ULN; SCr>60ml/min/m2;
Key exclusion criteria (6 listed)
- ALK positive anaplastic T-cell lymphoma;
- NK / T cell lymphoma, nasal type;
- Uncontrolled active infection;
- Acute myocardial infarction or unstable angina pectoris within 6 months; uncontrolled hypertension, symptomatic arrhythmia, etc;
- Subjects who are known or suspected to be unable to comply with the study protocol;
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 |
|---|---|---|
| Tucidinostat, Azacitidine combined with CHOPAzacitidine: 200 mg D1200 mg D2100 mg D3 subcutaneous injection Tucidinostat: 20mg / time, D1, 4, 8, 11; Take medicine with 200ml warm boiled water 30 minutes after breakfast. CHOP chemotherapy: * Cyclophosphamide (CTX) 750mg / m2 intravenous infusion, day 1; * Epirubicin (EPI) 70mg / m2 intravenous infusion, day 1; * Vinoresin (VDS) 4mg intravenous infusion, day 1; * Prednisone 100mg orally, day 1-5. Every 21 days is a course of treatment | Drug | CHOP, Tucidinostat, Azacitidine combined with CHOP |
Primary outcome
Overall response rate (ORR)
Time frame: 6 course of treatment (each cycle is 21 days)
the total proportion of patients with complete response (CR) and partial response (PR)
3 secondary outcomes
2-year progression-free survival（PFS）
Time frame: 2 years
2-year overall survival（OS）
Time frame: 2 years
Incidence and severity of adverse events, serious adverse events and other safety parameters
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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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. This study is not recruiting at the moment.
Daobin Zhou study chair
Department of Hematology, Peking University First Hospital
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 Tucidinostat, Azacitidine combined with CHOP in people with T-cell Lymphoma, run by Peking Union Medical College 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhang (+861069156874, zhangyan10659@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 6 course of treatment (each cycle is 21 days)). 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 9 Apr 2024.