Status:
UNKNOWN
Sintilimab Plus Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Phase II Study
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Peking University Third Hospital
Beijing Longfu Hospital
Conditions:
Cutaneous T-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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/refra...
Detailed Description
This is a single-arm phase 2 study with fixed does of combined Sintilimab and Chidamide regimen. This regimen is repeated every 21 days. Sintilimab (200mg) is administered intravenously on day 1 of ev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04296786
Start Date
November 1 2019
End Date
December 1 2024
Last Update
March 5 2020
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730