Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients

NCT07074457 | Recruiting

• 1 other identifier: 2024470
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

CD30+ Peripheral T-cell Lymphoma

Keywords

Chidamide; Brentuximab vedotin; Unfit for chemotherapy

Outcome Measures

Primary Outcomes (1)

• Complete response rate(CRR)

  The rate of patients who achieved CR after 3 cycles of BvC regimen

  At the end of 3 cycles of BvC (each cycle is 21 days)

Secondary Outcomes (4)

• Main adverse reactions

  From enrollment to 1 month after consolidation treatment of the last patient

• 2-year overall survival(OS)

  From enrollment to 2 year after treatment of the last patient

• Overall response rate(ORR)

  At the end of 3 cycles of BvC (each cycle is 21 days)

• 2-year progression-free survival(PFS)

  From enrollment to 2 year after treatment of the last patient

Study Arms (2)

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

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

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

Interventions

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.;

Cohort 1 (patients achieved CR); Cohort 2 (patients achieved PR)

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

Cohort 1 (patients achieved CR); Cohort 2 (patients achieved PR)

Maintenance therapy-chidamide DRUG

Chidamide (20mg biw for 2 weeks every 3 weeks, po.) for ≥2 years

Cohort 1 (patients achieved CR); Cohort 2 (patients achieved PR)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Interventions

Brentuximab Vedotin; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Central Study Contacts

Zhengming Jin

CONTACT

67781856; jinzhengming519519@163.com

Changju Qu

CONTACT

67781856; qcj310@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 20, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

CN (1)