CD30+ Peripheral T-cell LymphomaNCT07074457
Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients
A study testing Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide), Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide) and Maintenance therapy-chidamide in people with CD30+ Peripheral T-cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of chidamide combined with brentuximab vedotin regimen for CD30 positive PTCL patients who are unfit for chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CD30+ Peripheral T-cell Lymphoma
- What is being tested?
- Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide), Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide) and Maintenance therapy-chidamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2028
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥70 years or age < 70 years and unfit for chemotherapy, male or female not limited;
- Patients must have the capacity to understand and willingly provide written informed consent;
- ECOG score 0-3 points;
- Expected lifespan>3 months;
- Patients with CD30+ peripheral T-cell lymphoma (PTCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of Diseases;
- Measurable lesions with a short diameter of ≥15mm defined by PET/CT.
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- R/R PTCL: patients with at least previous first-line treatment failure and no prior exposure to chidamide and brentuximab vedotin.
- Patients are unfit for chemotherapy after evaluation or are not considered for chemotherapy for other reasons;
- Any non-hematological toxicity, except hair loss, associated with prior treatment in patients with R/R disease, as per NCI CTCAE version 5.0, must be managed and resolved to at least grade 1;
- Appropriate organ function: Cardiac function: ejection fraction ≥ 50%, asymptomatic arrhythmia; Liver function: alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal, total bilirubin<2 times the upper limit of normal; Renal function: serum creatinine clearance rate ≥ 80 mL/min, creatinine<160 umol/l; Pulmonary function: Without oxygen inhalation, SPO2>90%, FEV1, FVC, and DLCO ≥ 50% predicted values;
- Adequate bone marrow reserve is defined as: Hemoglobin ≥ 9g/dL, Platelet count ≥ 70 × 10 ^ 9/L, The absolute value of neutrophils is ≥ 1.0 × 10 ^ 9/L, If accompanied by bone marrow invasion, platelet count ≥ 50 × 10 ^ 9/L, absolute neutrophil count ≥ 0.75 × 10 ^ 9/L, The number of CD34+cells is ≥ 2.0 × 109/kg;
- Subjects with fertility or potential for fertility must be willing to undergo contraception from the date of registration in this study until the study follow-up period;
- Patients with good compliance.
Who cannot join
- Patients with R/R disease previously used chidamide and brentuximab vedotin or received any other anti-tumor therapy within 4 weeks.
- Patients enrolled in another clinical study within 4 weeks;
- HIV infection and/or active hepatitis B or C;
- Uncontrolled active infections;
- Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine>3 times the upper limit of normal);
- Existence of organic heart disease or severe arrhythmia, leading to clinical symptoms or abnormal heart function (NYHA functional class ≥ 2);
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- Simultaneously present other tumors that require treatment or intervention;
- Previous or current history of vascular embolism;
- Pregnant or lactating women;
- In a state of severe immune suppression;
- Other psychological conditions that hinder patients from participating in research or signing informed consent forms.
- Patients are unlikely to complete all protocol study visits and procedures or do not meet the requirements for study participation.
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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Zhengming Jin, 67781856, jinzhengming519519@163.com
Changju Qu, 67781856, qcj310@163.com
About this study
Official title: A Prospective, Exploratory Clinical Study of Chidamide Combined With Brentuximab Vedotin Regimen in the Treatment of CD30 Positive PTCL Patients Unfit for Chemotherapy
To evaluate the efficacy and safety of chidamide combined with brentuximab vedotin regimen for CD30 positive PTCL patients who are unfit for chemotherapy.
Read the detailed description
This study will enroll CD30-positive peripheral T-cell lymphoma (PTCL) patients who are ineligible for conventional chemotherapy. Participants will receive induction therapy with 3 cycles of BvC regimen (brentuximab vedotin plus chidamide combination). Patients demonstrating disease progression (PD) or stable disease (SD) will be withdrawn from the study. Patients achieving partial remission(PR) or complete remission(CR) will receive stratification consolidation therapy as followings:
Cohort 1 (patients achieved CR): Receive 3 additional cycles of BvC consolidation
Cohort 2 (patients achieved PR): Receive 6 additional cycles of BvC consolidation
After consolidation therapy, responding patients (CR/PR) will receive chidamide maintenance therapy for ≥2 years
- Conditions
- CD30+ Peripheral T-cell Lymphoma
- Being tested
- Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide), Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide), Maintenance therapy-chidamide
- Keywords
- Chidamide, Brentuximab vedotin, Unfit for chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide)Drug
3 cycles of BvC treatment for all enrolled patients.
Brentuximab vedotin; Specification: 50mg per vial; 1.8mg/kg qd d1 every 3 weeks, ivgtt.;
Chidamide; Specification: 5mg per tablet; 20mg biw for 2 weeks every 3 weeks, po.;
Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide)Drug
Consolidation therapy( For patients who achieved CR after induction therapy, 3 cycles of additional BvC treatment; For patients who achieved PR after induction therapy, 6 cycles of additional BvC treatment).
Brentuximab vedotin; Specification: 50mg per vial; 1.8mg/kg qd d1 every 3 weeks, ivgtt.;
Chidamide; Specification: 5mg per tablet; 20mg biw for 2 weeks every 3 weeks, po.;
Maintenance therapy chidamide (20mg biw for 2 weeks every 3 weeks, po.) for ≥2 years
Maintenance therapy-chidamideDrug
Chidamide (20mg biw for 2 weeks every 3 weeks, po.) for ≥2 years
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (patients achieved CR) | Experimental | Patients achieving CR after 3 cycles of BvC therapy will receive 3 additional cycles of BvC consolidation followed by chidamide maintenance therapy for ≥2 years Receives: Drug: Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide); Drug: Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide); Drug: Maintenance therapy-chidamide |
| Cohort 2 (patients achieved PR) | Experimental | Patients achieving PR after 3 cycles of BvC therapy will receive 6 additional cycles of BvC consolidation followed by chidamide maintenance therapy for ≥2 years Receives: Drug: Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide); Drug: Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide); Drug: Maintenance therapy-chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate(CRR)
The rate of patients who achieved CR after 3 cycles of BvC regimen
Measured: At the end of 3 cycles of BvC (each cycle is 21 days)
Secondary outcomes (4)
Main adverse reactions
The safety and tolerability of the therapeutic regimen measured by the major adverse events.
Measured: From enrollment to 1 month after consolidation treatment of the last patient
2-year overall survival(OS)
OS will be assessed from the start of the combination regimen to the date of death or end of follow-up.
Measured: From enrollment to 2 year after treatment of the last patient
Overall response rate(ORR)
The rate of patients who achieved CR or PR after 3 cycles of BvC regimen
Measured: At the end of 3 cycles of BvC (each cycle is 21 days)
2-year progression-free survival(PFS)
PFS will be assessed from the first drug given to the date of progression, relapse, death or end of follow-up.
Measured: From enrollment to 2 year after treatment of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Nov 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD30+ Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074457
- Sponsor's protocol ID
- 2024470
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 20 Jul 2025
- 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 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Exploratory Clinical Study of Chidamide Combined With Brentuximab Vedotin Regimen in the Treatment of CD30 Positive PTCL Patients Unfit for Chemotherapy
- ClinicalTrials.gov ID
- NCT07074457
- Acronym / sponsor ID
- 2024470
- Conditions
- CD30+ Peripheral T-cell Lymphoma
- Keywords
- Chidamide, Brentuximab vedotin, Unfit for chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 20 Jul 2025 (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 and safety of chidamide combined with brentuximab vedotin regimen for CD30 positive PTCL patients who are unfit for chemotherapy.
Detailed description
This study will enroll CD30-positive peripheral T-cell lymphoma (PTCL) patients who are ineligible for conventional chemotherapy. Participants will receive induction therapy with 3 cycles of BvC regimen (brentuximab vedotin plus chidamide combination). Patients demonstrating disease progression (PD) or stable disease (SD) will be withdrawn from the study. Patients achieving partial remission(PR) or complete remission(CR) will receive stratification consolidation therapy as followings:
Cohort 1 (patients achieved CR): Receive 3 additional cycles of BvC consolidation
Cohort 2 (patients achieved PR): Receive 6 additional cycles of BvC consolidation
After consolidation therapy, responding patients (CR/PR) will receive chidamide maintenance therapy for ≥2 years
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (patients achieved CR) | Experimental | Drug: Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide), Drug: Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide), Drug: Maintenance therapy-chidamidePatients achieving CR after 3 cycles of BvC therapy will receive 3 additional cycles of BvC consolidation followed by chidamide maintenance therapy for ≥2 years |
| Cohort 2 (patients achieved PR) | Experimental | Drug: Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide), Drug: Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide), Drug: Maintenance therapy-chidamidePatients achieving PR after 3 cycles of BvC therapy will receive 6 additional cycles of BvC consolidation followed by chidamide maintenance therapy for ≥2 years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥70 years or age < 70 years and unfit for chemotherapy, male or female not limited;
- Patients must have the capacity to understand and willingly provide written informed consent;
- ECOG score 0-3 points;
- Expected lifespan>3 months;
- Patients with CD30+ peripheral T-cell lymphoma (PTCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of Diseases;
Key exclusion criteria (12 listed)
- Patients with R/R disease previously used chidamide and brentuximab vedotin or received any other anti-tumor therapy within 4 weeks.
- Patients enrolled in another clinical study within 4 weeks;
- HIV infection and/or active hepatitis B or C;
- Uncontrolled active infections;
- Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine>3 times the upper limit of normal);
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 |
|---|---|---|
| Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide)3 cycles of BvC treatment for all enrolled patients. Brentuximab vedotin; Specification: 50mg per vial; 1.8mg/kg qd d1 every 3 weeks, ivgtt.; Chidamide; Specification: 5mg per tablet; 20mg biw for 2 weeks every 3 weeks, po.; | Drug | Cohort 1 (patients achieved CR), Cohort 2 (patients achieved PR) |
| Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide)Consolidation therapy( For patients who achieved CR after induction therapy, 3 cycles of additional BvC treatment; For patients who achieved PR after induction therapy, 6 cycles of additional BvC treatment). Brentuximab vedotin; Specification: 50mg per vial; 1.8mg/kg qd d1 every 3 weeks, ivgtt.; Chidamide; Specification: 5mg per tablet; 20mg biw for 2 weeks every 3 weeks, po.; Maintenance therapy chidamide (20mg biw for 2 weeks every 3 weeks, po.) for ≥2 years | Drug | Cohort 1 (patients achieved CR), Cohort 2 (patients achieved PR) |
| Maintenance therapy-chidamideChidamide (20mg biw for 2 weeks every 3 weeks, po.) for ≥2 years | Drug | Cohort 1 (patients achieved CR), Cohort 2 (patients achieved PR) |
Primary outcome
Complete response rate(CRR)
Time frame: At the end of 3 cycles of BvC (each cycle is 21 days)
The rate of patients who achieved CR after 3 cycles of BvC regimen
4 secondary outcomes
Main adverse reactions
Time frame: From enrollment to 1 month after consolidation treatment of the last patient
2-year overall survival(OS)
Time frame: From enrollment to 2 year after treatment of the last patient
Overall response rate(ORR)
Time frame: At the end of 3 cycles of BvC (each cycle is 21 days)
2-year progression-free survival(PFS)
Time frame: From enrollment to 2 year after treatment of the last patient
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 20 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide), Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide) and Maintenance therapy-chidamide in people with CD30+ Peripheral T-cell Lymphoma, run by The First Affiliated Hospital of Soochow 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 13 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 20 Jul 2025. 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.
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?
Contact Zhengming Jin (67781856, jinzhengming519519@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate(CRR) (time frame: At the end of 3 cycles of BvC (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 20 Jul 2025.