NCT04994210
Recruiting
Phase 2
Safety and Efficacy of Sintilimab(S) in Combination With Histone Deacetylase Inhibitor (Chidamide, C) in Newly Diagnosed Extranodal Natural Killer Cell/T-cell Lymphoma(EN): A Single-arm, Multicenter Phase II Study(SCENT-2)
Sun Yat-sen University1 site in 1 country30 target enrollmentStarted: October 4, 2021Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Sun Yat-sen University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR) after end of treatment
Overview
Brief Summary
ENKTL is a highly aggressive NHL with a higher incidence in Asia. L-asparaginase containing chemotherapy regimens are the standard first-line treatment with apparently toxicities. In 2020 ASH, the investigators reported Sintilimab(anti-PD-1 antibody) plus Chidamide(an oral subtype-selective HDACi) yielded effective antitumor activity, durable response in patients with relapsed or refractory ENKTL(SCENT trial. Abstracts 644). The investigators next conducted a exploratory study to investigated the safety and efficacy of Sintilimab plus Chidamide(SC) for patients with newly diagnosed ENKTL(SCENT-2 trial).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Volunteer to participate in clinical research; fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures;
- •Aged 18-80 years old male or female;
- •Extranodal NK/T-cell lymphoma confirmed by histopathology examination;
- •Untreated,without any anti-lymphoma treatment;
- •Paraffin tissue specimens or fresh puncture tissue specimens are available;
- •Eastern cooperative oncology group score: 0-2;
- •Estimated survival ≥ 12 months;
- •There must be at least one evaluate able or measurable lesion that meets the lymphoma response to immunomodulatory therapy criteria (LYRIC) \[evaluable lesion: 18F-fluorodeoxyglucose/Positron Emission Tomography (18FDG/PET) examination showing increased lymph node or extranodal uptake (higher than liver) and PET and/or computed tomography (Computed Tomography) CT) features are consistent with lymphoma findings; lesions can be measured: nodular lesions \> 15mm or extranodal lesions \> 10mm (if the only measurable lesion has received radiotherapy in the past, there must be evidence of radiological progress after radiotherapy), and accompanied by increased 18FDG uptake). Except for this, there is no measurable increase in diffuse 18FDG uptake in the liver;
- •Adequate organ and bone marrow function, no severe hematopoietic dysfunction, cardiac, pulmonary, liver, kidney, thyroid dysfunction and immune deficiency (no blood transfusion, granulocyte colony stimulating factor or other medical support was received within 14 days prior to the use of the research drug): 1) The absolute value of neutrophils (\>1.0×10\^9/L); 2) platelet count (\> 75×10\^9/L); 3) Hemoglobin (\> 9 g/dL); 4) Upper Limit Normal (ULN) or creatinine clearance rate (\>40 mL/min) of serum creatinine (\<1.5 times normal value upper limit) (estimated by Cockcroft-Gault formula); 5) Serum total bilirubin \< 1.5 times ULN; 6) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) = 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR) = 1.5 times ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) = 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are using anticoagulant therapy at screening time). Within the expected range; 8) Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were all within the normal range (+10%);
- •There was no evidence that subjects had difficulty breathing at rest, and the measured value of pulse oximetry at rest was more than 92%;
Exclusion Criteria
- •Invasive natural killer cell leukemia;
- •Hemophagocytic syndrome;
- •Primary central nervous system lymphoma or secondary central nervous system involvement;
- •Relapsed or refractory ENKTL, accpeted any anti-ENKTL treatment;
- •Received organ transplantation in the past;
- •Participating in other clinical studies or planning to start this study is less than 4 weeks from the end of the previous clinical study;
- •Patients with active autoimmune diseases requiring systematic treatment in the past two years (hormone replacement therapy is not considered systematic treatment, such as type I diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, adrenocortical dysfunction or pituitary dysfunction requiring only physiological doses of glucocorticoid replacement therapy); Patients with autoimmune diseases who do not require systematic treatment within two years can be enrolled;
- •Begin the study on subjects requiring systemic glucocorticoid therapy or other immunosuppressive therapy for a given condition within 14 days before treatment \[allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy (with very low systemic absorption); and allowing short-term (\< 7 days) glucocorticoid prophylaxis (e.g., contrast agent overdose) Sensitivity) or for the treatment of non-autoimmune diseases (e.g. delayed hypersensitivity caused by contact allergens);
- •In the past five years, patients with other malignant tumors have undergone radical treatment, except for basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of breast and carcinoma in situ of cervix;
- •Start the study and receive Chinese herbal medicine or Chinese patent medicine treatment within 7 days before treatment;
Arms & Interventions
Sintilimab+Chidamide
Experimental
Sintilimab：200mg(fixed dosage), ivd, qd, q21d Chidamide: 30mg,biw,continued oral
Intervention: Sintilimab (Drug)
Sintilimab+Chidamide
Experimental
Sintilimab：200mg(fixed dosage), ivd, qd, q21d Chidamide: 30mg,biw,continued oral
Intervention: Chidamide (Drug)
Outcomes
Primary Outcomes
Objective response rate (ORR) after end of treatment
Time Frame: up to 24 months
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Complete response rate (CRR) after end of treatment
Time Frame: up to 24 months
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Partial response rate (PRR) after end of treatment
Time Frame: up to 24 months
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Secondary Outcomes
- Progression-Free Survival (PFS)(Time Frame: up to 36 months)
- Objective response rate (ORR) after sintilimab plus chidamide(up to 24 months)
- Complete response rate (CRR) after sintilimab plus chidamide(up to 24 months)
- Overall Survival (OS)(up to 36 months)
- Time to progression (TTP)(Up to 36 months)
- Duration of Response (DOR)(up to 36 months)
- Time to disease response (TTR)(up to 36 months)
- The frequency of adverse events (adverse events, AEs) and serious adverse events (SAEs)(Up to 36 months)
- Partial response rate (PRR) after sintilimab plus chidamide(up to 24 months)
Investigators
Huiqiang Huang
professor
Sun Yat-sen University
Study Sites (1)
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