Chidamide plus brentuximab vedotin for CD30-positive peripheral T‑cell lymphoma in patients unfit for chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional protocol enrolls CD30-positive peripheral T‑cell lymphoma patients who are ineligible for conventional chemotherapy, including relapsed/refractory cases without prior exposure to chidamide or brentuximab vedotin. Participants receive three induction cycles of brentuximab vedotin plus chidamide (BvC), and those with progressive or stable disease are withdrawn. Patients achieving partial or complete remission proceed to consolidation—three further BvC cycles for complete responders and six for partial responders—followed by chidamide maintenance for at least two years. Safety, tolerability, and disease response are monitored with imaging and clinical assessments throughout treatment and follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥70 years or age \< 70 years and unfit for chemotherapy, male or female not limited;
2. Patients must have the capacity to understand and willingly provide written informed consent;
3. ECOG score 0-3 points;
4. Expected lifespan\>3 months;
5. Patients with CD30+ peripheral T-cell lymphoma (PTCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of Diseases;
6. Measurable lesions with a short diameter of ≥15mm defined by PET/CT.
7. R/R PTCL: patients with at least previous first-line treatment failure and no prior exposure to chidamide and brentuximab vedotin.
8. Patients are unfit for chemotherapy after evaluation or are not considered for chemotherapy for other reasons;
9. 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;
10. 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;
11. 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;
12. 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;
13. Patients with good compliance.

Exclusion Criteria:

1. Patients with R/R disease previously used chidamide and brentuximab vedotin or received any other anti-tumor therapy within 4 weeks.
2. Patients enrolled in another clinical study within 4 weeks;
3. HIV infection and/or active hepatitis B or C;
4. Uncontrolled active infections;
5. Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine\>3 times the upper limit of normal);
6. Existence of organic heart disease or severe arrhythmia, leading to clinical symptoms or abnormal heart function (NYHA functional class ≥ 2);
7. Simultaneously present other tumors that require treatment or intervention;
8. Previous or current history of vascular embolism;
9. Pregnant or lactating women;
10. In a state of severe immune suppression;
11. Other psychological conditions that hinder patients from participating in research or signing informed consent forms.
12. Patients are unlikely to complete all protocol study visits and procedures or do not meet the requirements for study participation.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Zhengming Jin
• Email: jinzhengming519519@163.com
• Phone: 67781856

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.