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

A Prospective, Exploratory Clinical Study of Chidamide Combined With Brentuximab Vedotin Regimen in the Treatment of CD30 Positive PTCL Patients Unfit for Chemotherapy

This treatment will test whether combining chidamide with brentuximab vedotin helps people with CD30-positive peripheral T‑cell lymphoma who cannot tolerate standard chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 47 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: brentuximab, chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07074457 on ClinicalTrials.gov

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three induction cycles of brentuximab vedotin plus chidamide (BvC), and those with progressive or stable disease are withdrawn.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.

Who should consider this trial

Good fit: Adults with CD30-positive peripheral T‑cell lymphoma who are unfit for or decline conventional chemotherapy, have ECOG 0–3, measurable disease, and no prior exposure to chidamide or brentuximab vedotin are ideal candidates.

Not a fit: Patients who progress or have stable disease during induction, those with prior exposure to either study drug, or those with inadequate organ function are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, this regimen could provide an effective, lower-intensity treatment option to control CD30-positive PTCL in patients who cannot receive standard chemotherapy.

How similar studies have performed: Brentuximab vedotin has proven activity in CD30-positive lymphomas and chidamide has shown benefit in PTCL, but the specific combination has limited published data and remains relatively untested.

Eligibility criteria

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 this trial is running

Suzhou, Jiangsu

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

Study contacts

• Study coordinator: Zhengming Jin

Conditions CD30+ Peripheral T-cell Lymphoma; Chidamide; Brentuximab vedotin; Unfit for chemotherapy