PTCLPhase 2NCT06492629
Toripalimab Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma
A Phase 2 study testing Toripalimab and chidamide in people with PTCL, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To evaluate the efficacy of Toripalimab combined with Chidamide in the treatment of relapsed/refractory peripheral T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTCL
- What is being tested?
- Toripalimab and chidamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2024to 31 Dec 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older, both males and females are eligible;
- Histologically confirmed peripheral T-cell lymphoma (PTCL) that has relapsed or is refractory after at least one line of systemic therapy. The definitions are as follows:
- Relapse: Patients who achieved a Complete Response (CR) in previous treatments and have new lesions at the original site or elsewhere; Refractory: Patients who did not achieve CR after adequate treatment. For nasal-type NK/T-cell lymphoma, previous treatments must have included a chemotherapy regimen containing asparaginase;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
- Expected survival of at least 3 months;
- At least one measurable lesion in two dimensions, with the following criteria:
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- For intra-nodular lesions: Longest diameter >1.5 cm, shortest diameter >1.0 cm; For extra-nodular lesions: Longest diameter >1.0 cm;
- Adequate organ function as follows (no use of blood components or cytokines within 14 days before the first administration of the study drug): Hematology: Neutrophil count (NEUT) ≥ 1.5 × 10^9/L, Platelet count (PLT) ≥ 75
- 10^9/L, Hemoglobin (HGB) ≥ 90 g/L; Liver function: Total serum bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 × ULN; if there is liver metastasis, TBIL ≤ 3 × ULN, ALT and AST ≤ 5 × ULN; Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN; Thyroid function: Thyroid-stimulating hormone (TSH) within the normal range; if TSH is abnormal, Free Triiodothyronine (FT3) and Free Thyroxine (FT4) should be within the normal range or abnormal without clinical significance;
- Signed an informed consent form and is able to comply with the visits and procedures specified in the protocol.
Who cannot join
- Diagnosed with Adult T-cell Leukemia/Lymphoma (ATLL);
- Confirmed central nervous system (CNS) infiltration of lymphoma, including brain parenchymal invasion, meningeal involvement, or spinal cord compression;
- T-cell lymphoma primarily starting extranodally in the skin, such as: Mycosis Fungoides/Sezary Syndrome (MF/SS), primary cutaneous CD30-positive T-cell lymphoproliferative disorders, primary cutaneous δγT-cell lymphoma, primary cutaneous CD8-positive aggressive, epidermotropic cytotoxic T-cell lymphoma, primary cutaneous acral CD8-positive T-cell lymphoma, lymphomatoid papulosis, primary cutaneous CD4-positive small to medium T-cell lymphoproliferative disorders;
- Patients who have previously used PD-1 monoclonal antibodies/PD-L1 monoclonal antibodies or Chidamide;
- Patients with certain specific past medical histories, such as active autoimmune diseases, type 1 diabetes, thyroid hormone replacement required for hypothyroidism (except Hashimoto's thyroiditis), severe mental illness;
- Patients who require the use of immunosuppressants or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose >10mg/d prednisone or other equivalent efficacy hormones) within 14 days before the first administration or during the study;
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- Patients who have received radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy, or systemic treatment with antibody drugs within 4 weeks before the first administration; those who have used monoclonal antibody conjugated with radioactive isotopes or cytotoxins within 10 weeks before the first administration; patients who have not recovered to ≤grade 1 toxicity from previous anti-tumor treatments (except for alopecia);
- Patients with uncontrolled hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥100mmHg);
- Patients who have undergone autologous stem cell transplantation within 3 months before the first administration;
- Patients with a history of organ transplantation or allogeneic bone marrow transplantation;
- Patients who have received or plan to receive live attenuated vaccines within 4 weeks before the first administration or during the study;
- Patients with a history of allergy to macromolecular protein preparations or anti-PD-1 antibodies;
- Patients with a history of or concurrent other malignant tumors (except for skin basal cell carcinoma and cervical carcinoma in situ that have been cured for more than 3 years);
- Patients with uncontrollable or severe cardiovascular diseases, those who have had New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction, and other cardiovascular diseases within 6 months before the first administration;
- HIV-positive patients, or those with active hepatitis (for hepatitis B: reference to hepatitis B five items and HBV-DNA, transaminases, etc., for hepatitis C: reference to HCV antibodies and HCV RNA);
- Patients who have received any other clinical trial drugs/devices within 4 weeks before the first administration;
- Patients with a history of drug abuse or alcoholism within 6 months before the first administration;
- Patients with a history of or concurrent interstitial lung disease (except for interstitial lung disease caused by radiochemotherapy and currently asymptomatic);
- Patients with active infections requiring systemic treatment;
- Patients with active pulmonary tuberculosis infection;
- Pregnant or lactating women;
- Patients deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medical Oncology
Beijing, Beijing Municipality, 100021
About this study
Official title: Phase II Clinical Study of Toripalimab Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma
To evaluate the efficacy of Toripalimab combined with Chidamide in the treatment of relapsed/refractory peripheral T-cell lymphoma.
Read the detailed description
The study is an open-label, single-arm, single-center, Phase II clinical trial. The trial design adopts the Simon optimal two-stage design. The number of effective cases in the first stage is 15; if fewer than 5 effective cases are observed, the trial will be terminated, otherwise, the trial will continue. The total sample size for the trial is at least 43 cases. All subjects receive treatment with the Toripalimab and Chidamide regimen until the subject has been treated for 2 years, disease progression occurs, intolerable toxic reactions occur, or treatment is terminated for other reasons, whichever comes first. After the end of treatment, subjects are required to complete the end-of-treatment visit within 7 days. Safety follow-up after the last dose is required at 30 days (±7 days) and 90 days (±7 days) after the last dose, with adverse event (AE) collection up to 90 days after the last dose. After the end of dosing, subjects enter the follow-up period with a telephone follow-up every 12 weeks (±7 days) to collect survival information and subsequent anti-tumor treatments until death or loss to follow-up. If a subject discontinues treatment for reasons other than PD (progressive disease), efficacy evaluation should continue at the same frequency as during the dosing period until the subject experiences PD, starts a new anti-tumor treatment, dies, or is lost to follow-up.
Treatment should be continued as long as clinical benefit is observed, until the patient is no longer tolerating it, for a maximum of 2 years of treatment. Atypical responses may be observed (for example, a temporary increase in tumor size or the appearance of new small lesions within the first few months, followed by a reduction in tumor size). If the patient's clinical symptoms are stable or continue to improve, even with preliminary evidence of disease progression, based on the overall judgment of clinical benefit, it may be considered to continue treatment with this regimen until disease progression is confirmed.
- Conditions
- PTCL
- Being tested
- Toripalimab, chidamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Intravenous infusion, 240mg, administered once every 3 weeks, until the subject has been treated for 2 years, disease progression occurs, intolerable toxic reactions are experienced, or treatment is discontinued for other reasons.
chidamideDrug
Take 30 mg (6 tablets) each time, and take the medication twice a week, with at least 3 days between doses (such as on Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), to be taken 30 minutes after meals.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab Combined With Chidamide group | Experimental | Toripalimab:Intravenous infusion, 240mg, administered once every 3 weeks. Chidamide:Take 30 mg (6 tablets) each time, and take the medication twice a week, with at least 3 days between doses Receives: Drug: Toripalimab; Drug: chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The primary efficacy endpoint will be assessed based on the Lugano 2014 criteria for Objective Response Rate (ORR), which includes both Complete Response (CR) and Partial Response (PR).
Measured: 24months
Secondary outcomes (1)
Overall Survival (OS)
The time from the start of the trial to death from any cause
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start3 Apr 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTCLStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHENGYANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492629
- Sponsor's protocol ID
- PTCL-001
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Toripalimab Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06492629
- Acronym / sponsor ID
- PTCL-001
- Conditions
- PTCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jul 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.
To evaluate the efficacy of Toripalimab combined with Chidamide in the treatment of relapsed/refractory peripheral T-cell lymphoma.
Detailed description
The study is an open-label, single-arm, single-center, Phase II clinical trial. The trial design adopts the Simon optimal two-stage design. The number of effective cases in the first stage is 15; if fewer than 5 effective cases are observed, the trial will be terminated, otherwise, the trial will continue. The total sample size for the trial is at least 43 cases. All subjects receive treatment with the Toripalimab and Chidamide regimen until the subject has been treated for 2 years, disease progression occurs, intolerable toxic reactions occur, or treatment is terminated for other reasons, whichever comes first. After the end of treatment, subjects are required to complete the end-of-treatment visit within 7 days. Safety follow-up after the last dose is required at 30 days (±7 days) and 90 days (±7 days) after the last dose, with adverse event (AE) collection up to 90 days after the last dose. After the end of dosing, subjects enter the follow-up period with a telephone follow-up every 12 weeks (±7 days) to collect survival information and subsequent anti-tumor treatments until death or loss to follow-up. If a subject discontinues treatment for reasons other than PD (progressive disease), efficacy evaluation should continue at the same frequency as during the dosing period until the subject experiences PD, starts a new anti-tumor treatment, dies, or is lost to follow-up.
Treatment should be continued as long as clinical benefit is observed, until the patient is no longer tolerating it, for a maximum of 2 years of treatment. Atypical responses may be observed (for example, a temporary increase in tumor size or the appearance of new small lesions within the first few months, followed by a reduction in tumor size). If the patient's clinical symptoms are stable or continue to improve, even with preliminary evidence of disease progression, based on the overall judgment of clinical benefit, it may be considered to continue treatment with this regimen until disease progression is confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab Combined With Chidamide group | Experimental | Drug: Toripalimab, Drug: chidamideToripalimab:Intravenous infusion, 240mg, administered once every 3 weeks. Chidamide:Take 30 mg (6 tablets) each time, and take the medication twice a week, with at least 3 days between doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 years or older, both males and females are eligible;
- Histologically confirmed peripheral T-cell lymphoma (PTCL) that has relapsed or is refractory after at least one line of systemic therapy. The definitions are as follows:
- Relapse: Patients who achieved a Complete Response (CR) in previous treatments and have new lesions at the original site or elsewhere; Refractory: Patients who did not achieve CR after adequate treatment. For nasal-type NK/T-cell lymphoma, previous treatments must have included a chemotherapy regimen containing asparaginase;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
- Expected survival of at least 3 months;
Key exclusion criteria (22 listed)
- Diagnosed with Adult T-cell Leukemia/Lymphoma (ATLL);
- Confirmed central nervous system (CNS) infiltration of lymphoma, including brain parenchymal invasion, meningeal involvement, or spinal cord compression;
- T-cell lymphoma primarily starting extranodally in the skin, such as: Mycosis Fungoides/Sezary Syndrome (MF/SS), primary cutaneous CD30-positive T-cell lymphoproliferative disorders, primary cutaneous δγT-cell lymphoma, primary cutaneous CD8-positive aggressive, epidermotropic cytotoxic T-cell lymphoma, primary cutaneous acral CD8-positive T-cell lymphoma, lymphomatoid papulosis, primary cutaneous CD4-positive small to medium T-cell lymphoproliferative disorders;
- Patients who have previously used PD-1 monoclonal antibodies/PD-L1 monoclonal antibodies or Chidamide;
- Patients with certain specific past medical histories, such as active autoimmune diseases, type 1 diabetes, thyroid hormone replacement required for hypothyroidism (except Hashimoto's thyroiditis), severe mental illness;
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 |
|---|---|---|
| ToripalimabIntravenous infusion, 240mg, administered once every 3 weeks, until the subject has been treated for 2 years, disease progression occurs, intolerable toxic reactions are experienced, or treatment is discontinued for other reasons. | Drug | Toripalimab Combined With Chidamide group |
| chidamideTake 30 mg (6 tablets) each time, and take the medication twice a week, with at least 3 days between doses (such as on Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), to be taken 30 minutes after meals. | Drug | Toripalimab Combined With Chidamide group |
Primary outcome
Objective Response Rate (ORR)
Time frame: 24months
The primary efficacy endpoint will be assessed based on the Lugano 2014 criteria for Objective Response Rate (ORR), which includes both Complete Response (CR) and Partial Response (PR).
1 secondary outcome
Overall Survival (OS)
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: Undecided
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T-cell Lymphoma
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 Toripalimab and chidamide in people with PTCL, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 10 inclusion and 22 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 Jul 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?
Results are not available in the source record.
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?
Objective Response Rate (ORR) (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 9 Jul 2024.