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Recruiting NCT07074457

Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients

Trial Parameters

Condition CD30+ Peripheral T-cell Lymphoma
Sponsor The First Affiliated Hospital of Soochow University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 47
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-11-01
Completion 2028-08-01
Interventions
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

Brief Summary

To evaluate the efficacy and safety of chidamide combined with brentuximab vedotin regimen for CD30 positive PTCL patients who are unfit for chemotherapy.

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:

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