Sintilimab Plus Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Phase II Study

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of Sintilimab combined with Chidamide in the treatment of relapsed/refractory cutaneous T-cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Longfu Hospital; Dongzhimen Hospital, Beijing; Peking University Third Hospital

Criteria

Inclusion Criteria:

• Pathologically confirmed cutaneous T-cell lymphoma according World Health Organization (WHO) classification.

• ECOG≤2

• Patients with measurable lesions, with or without extra-dermal lesions, clinical stage of IIB-IVB.

• Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment.

• Absolute neutrophil count (ANC）≥0.75×109/L，platelet (PLT) ≥ 50×109/L，hemoglobin (HGB）≥ 80 g/L

• Thyroid stimulating hormone (TSH) within normal range

Exclusion Criteria:

• Pre-existing uncontrolled active infection

• Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN), total bilirubin (TBIL) >1.5 times ULN, serum creatinine >1.5 times ULN

• Patients with clinically significant QT interval prolongation (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), acute coronary syndrome (ACS) within 1 year, congestive heart failure (CHF), and symptomatic coronary heart disease.

• Patients who have received organ transplantation or hematopoietic stem cell transplantation.

• Active bleeding or recent thrombotic disease

• Patients with known interstitial lung disease

• Patients with active autoimmune disease or history of autoimmune disease in the past 2 years

• Patients with CNS involvement

• Pregnant or lactating women

• History of mental illness