Clinical trial · Interventional
Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients
A Prospective, Exploratory Clinical Study of Chidamide Combined With Brentuximab Vedotin Regimen in the Treatment of CD30 Positive PTCL Patients Unfit for Chemotherapy
NCT07074457CI-TRIAL-00092364recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of chidamide combined with brentuximab vedotin regimen for CD30 positive PTCL patients who are unfit for chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD30+ Peripheral T-cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide) | Drug | — | UNRESOLVED |
| Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide) | Drug | — | UNRESOLVED |
| Maintenance therapy-chidamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1 (patients achieved CR)
- description
- 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
- interventionNames
- 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
- type
- EXPERIMENTAL
- label
- Cohort 2 (patients achieved PR)
- description
- 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
- interventionNames
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.