Peripheral T Cell LymphomaPhase 2NCT06550336
A Clinical Study Assessing the Efficacy of Chidamide for CD30-positive Peripheral T-cell Lymphoma (PTCL).
A Phase 2 study testing Chidamide in people with Peripheral T Cell Lymphoma, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Objective:This study aims to assess the efficacy and safety of Chidamide as a monotherapy maintenance treatment for patients with newly diagnosed peripheral T-cell lymphoma (PTCL) who have achieved remission or stable disease after initial brentuximab vedotin (BV) plus cyclophosphamide, doxorubicin and prednisone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Chidamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 30 Dec 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the WHO 2016 diagnostic criteria, the histological diagnosis is confirmed as CD30+ peripheral T-cell lymphoma (PTCL), including peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALK- ALCL), enteropathy-associated T-cell lymphoma (EATL), and other pathological subtypes (excluding extranodal NK/T-cell lymphoma, nasal type [NKTCL]). Patients with newly diagnosed PTCL (excluding ALK+ ALCL), who have completed 6 cycles of first-line treatment regimens (including various first-line induction chemotherapy regimens, targeted drugs, other treatment plans, and various combined therapies, etc.; with or without the inclusion of Chidamide) and have achieved complete remission (CR), and are not suitable for or do not consider undergoing autologous hematopoietic stem cell transplantation. Within 12 weeks from the first day of the last cycle of their first-line treatment regimen, they start to receive the medication plan of this study.
- Age ≥18 years, male or female is not limited;
- ECOG performance status score 0-3;
- Neutrophils ≥1.5×10^9/L, platelets ≥80×10^9/L, hemoglobin ≥90g/L;
- Expected survival time ≥3 months;
- Voluntarily sign a written informed consent form.
Who cannot join
- Pregnant or lactating women and women of childbearing age who are unwilling to adopt contraceptive measures;
- Patients with a history of clinically significant prolongation of the QTc interval (males > 450ms, females > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), cardiac conduction block, myocardial infarction within the past year, congestive heart failure (CHF), and patients with symptomatic coronary artery disease requiring medication;
- Patients who have undergone organ transplantation;
- Patients who have received symptomatic treatment for previous bone marrow toxicity within 7 days prior to enrollment;
- Patients with active bleeding;
- Patients with a history of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related diseases;
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- Patients with active infection or those who have had persistent fever within 14 days prior to enrollment;
- Patients who have undergone major organ surgery within the past 6 weeks;
- Patients with abnormal liver function (total bilirubin > 1.5 times the normal value, ALT/AST > 2.5 times the normal value, or in liver-infiltrated patients ALT/AST > 5 times the normal value), and abnormal kidney function (serum creatinine > 1.5 times the normal value);
- Patients with mental disorders/those who are unable to give informed consent;
- Patients with drug abuse or chronic alcoholism that affects the evaluation of the trial results;
- Patients with lymphoma involving the central nervous system;
- Patients deemed by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
About this study
Official title: A Prospective, Single-center, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Chidamide Monotherapy for Maintenance Therapy in CD30+ Peripheral T-cell Lymphoma (PTCL).
- Objective:This study aims to assess the efficacy and safety of Chidamide as a monotherapy maintenance treatment for patients with newly diagnosed peripheral T-cell lymphoma (PTCL) who have achieved remission or stable disease after initial brentuximab vedotin (BV) plus cyclophosphamide, doxorubicin and prednisone (CHP)treatment, excluding ALK+ anaplastic large-cell lymphoma (ALCL).
- Design: The study is a prospective, single-center, open-label clinical trial.
- Treatment:Eligible patients will receive Chidamide tablets at a dosage of 20 mg (4 tablets) twice weekly. Treatment cycles are 4 weeks long and will continue until disease progression, unacceptable toxicity, patient withdrawal, investigator decision to discontinue, loss to follow-up, death, or study termination.
- Endpoints:The primary endpoint is the 2-year progression-free survival (PFS). Secondary endpoints include the overall response rate (ORR), overall survival (OS), and safety indicators.
- Rationale:The study seeks to provide a basis for the dosing regimen of Chidamide and contribute to the development of effective maintenance treatment strategies for PTCL patients.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Chidamide
- Keywords
- PTCL, chidamide
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
20 mg (4 tablets) twice a week, specifically on days 1, 4, 8, 11, 15, 18, 22, and 25.Each 4-week period constitutes one treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide maintenance arm | Experimental | 20 mg (4 tablets) twice a week, specifically on days 1, 4, 8, 11, 15, 18, 22, and 25. It should be administered orally 30 minutes after meals. Receives: Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival (PFS) rate
PFS was defined as the time between diagnosis and the first date of relapse or all-cause death, whichever occurred first.
Measured: 24months
Secondary outcomes (1)
overall survival (OS)
OS was defined as the time after the date of diagnosis until all-cause death.
Measured: 48months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start30 Jun 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (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 LymphomaStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Chidamide tablets,the medication is to be taken at a dose of 20 mg (4 tablets) twice a week, specifically on days 1, 4, 8, 11, 15, 18, 22, and 25. It should be administered orally 30 minutes after meals. Treatment Duration: Each 4-week period constitutes one treatment cycle. Throughout the trial, all participants will continue to receive treatment until any of the following occurs: disease progression, intolerable adverse reactions, or the participant decides to withdraw.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ou Bai, MD/PHD, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550336
- Sponsor's protocol ID
- CSIIT-01
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Chidamide Monotherapy for Maintenance Therapy in CD30+ Peripheral T-cell Lymphoma (PTCL).
- ClinicalTrials.gov ID
- NCT06550336
- Acronym / sponsor ID
- CSIIT-01
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- PTCL, chidamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 Aug 2024 (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.
- Objective:This study aims to assess the efficacy and safety of Chidamide as a monotherapy maintenance treatment for patients with newly diagnosed peripheral T-cell lymphoma (PTCL) who have achieved remission or stable disease after initial brentuximab vedotin (BV) plus cyclophosphamide, doxorubicin and prednisone (CHP)treatment, excluding ALK+ anaplastic large-cell lymphoma (ALCL).
- Design: The study is a prospective, single-center, open-label clinical trial.
- Treatment:Eligible patients will receive Chidamide tablets at a dosage of 20 mg (4 tablets) twice weekly. Treatment cycles are 4 weeks long and will continue until disease progression, unacceptable toxicity, patient withdrawal, investigator decision to discontinue, loss to follow-up, death, or study termination.
- Endpoints:The primary endpoint is the 2-year progression-free survival (PFS). Secondary endpoints include the overall response rate (ORR), overall survival (OS), and safety indicators.
- Rationale:The study seeks to provide a basis for the dosing regimen of Chidamide and contribute to the development of effective maintenance treatment strategies for PTCL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Chidamide tablets,the medication is to be taken at a dose of 20 mg (4 tablets) twice a week, specifically on days 1, 4, 8, 11, 15, 18, 22, and 25. It should be administered orally 30 minutes after meals. Treatment Duration: Each 4-week period constitutes one treatment cycle. Throughout the trial, all participants will continue to receive treatment until any of the following occurs: disease progression, intolerable adverse reactions, or the participant decides to withdraw.
| Arm | Type | Receives |
|---|---|---|
| Chidamide maintenance arm | Experimental | Drug: Chidamide20 mg (4 tablets) twice a week, specifically on days 1, 4, 8, 11, 15, 18, 22, and 25. It should be administered orally 30 minutes after meals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- According to the WHO 2016 diagnostic criteria, the histological diagnosis is confirmed as CD30+ peripheral T-cell lymphoma (PTCL), including peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALK- ALCL), enteropathy-associated T-cell lymphoma (EATL), and other pathological subtypes (excluding extranodal NK/T-cell lymphoma, nasal type [NKTCL]). Patients with newly diagnosed PTCL (excluding ALK+ ALCL), who have completed 6 cycles of first-line treatment regimens (including various first-line induction chemotherapy regimens, targeted drugs, other treatment plans, and various combined therapies, etc.; with or without the inclusion of Chidamide) and have achieved complete remission (CR), and are not suitable for or do not consider undergoing autologous hematopoietic stem cell transplantation. Within 12 weeks from the first day of the last cycle of their first-line treatment regimen, they start to receive the medication plan of this study.
- Age ≥18 years, male or female is not limited;
- ECOG performance status score 0-3;
- Neutrophils ≥1.5×10^9/L, platelets ≥80×10^9/L, hemoglobin ≥90g/L;
- Expected survival time ≥3 months;
Key exclusion criteria (13 listed)
- Pregnant or lactating women and women of childbearing age who are unwilling to adopt contraceptive measures;
- Patients with a history of clinically significant prolongation of the QTc interval (males > 450ms, females > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), cardiac conduction block, myocardial infarction within the past year, congestive heart failure (CHF), and patients with symptomatic coronary artery disease requiring medication;
- Patients who have undergone organ transplantation;
- Patients who have received symptomatic treatment for previous bone marrow toxicity within 7 days prior to enrollment;
- Patients with active bleeding;
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 |
|---|---|---|
| Chidamide20 mg (4 tablets) twice a week, specifically on days 1, 4, 8, 11, 15, 18, 22, and 25.Each 4-week period constitutes one treatment cycle. | Drug | Chidamide maintenance arm |
Primary outcome
2-year progression-free survival (PFS) rate
Time frame: 24months
PFS was defined as the time between diagnosis and the first date of relapse or all-cause death, whichever occurred first.
1 secondary outcome
overall survival (OS)
Time frame: 48months
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 29 Aug 2024.
- Individual participant dataSharing planned: No
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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.
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 2 study testing Chidamide in people with Peripheral T Cell Lymphoma, run by The First Hospital of Jilin University 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 13 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: under way, not looking for participants, as of the sponsor's last update on 29 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
2-year progression-free survival (PFS) rate (time frame: 24months). 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 29 Aug 2024.