A phase II study of Isatuximab and Cemiplimab in relapsed or refractory natural killer/T-cell lymphoid malignancy: Nick name – ICING study

Samsung Medical Center0 个研究点目标入组 37 人开始时间: 待定最近更新: 2021年10月5日

试验速览

阶段: 未知
状态: 招募中
发起方: Samsung Medical Center
入组人数: 37

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 19?(Year) 至 85?(Year)（—）
性别: All

入选标准

•?- Patients eligible for inclusion in this study must meet all of the following criteria
•1. Patients should be histologically diagnosed with extranodal NK/T-cell lymphoma or aggressive NK-cell leukemia.
•2. Patient should be previously treated with at least one type of chemotherapy regimen including autologous stem cell transplantation.
•3. Patient should have relapsed or refractory disease before enrollment.
•4. Patient written informed consent obtained prior to any screening procedures.
•5. Patient should be a male or female = 19 years (Maximum 85 years)
•6. Patient should have at least one measurable lesion on the CT or PET/CT scan. In case of PET/CT, diagnostic quality CT part of PET/CT is needed to define measurability. Cf. If a patient only has non-measurable lesion on the CT or PET/CT scan (e.g. bone marrow involvement, malignant effusion, and hemophagocytic lymphohistiocytosis), its association with disease progression or relapse should be determined by an investigator. Based on investigators’ decision, patients with non-measurable lesion could be enrolled.
•7. Patient should have an Eastern Cooperative Oncology Group (ECOG) performance status = 2 which is not declining during the last 2 weeks before the signature of the main study Informed Consent Form (S-ICF).
•8. Patient should have adequate bone marrow function as defined by the following laboratory values: Absolute Neutrophil Count (ANC) = 1.0 x 109/L; Platelets = 50 x 109/L; Hemoglobin = 8.0 g/dL Cf. If the cause of cytopenia is related with bone marrow involvement of tumor cells, a patient could be enrolled after blood transfusion or G-CSF support by investigator’s decision.
•9. Female patient should fulfill the following criteria 1) Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential; 2) Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 6 months after last administration of study drug if the risk of conception exists.
•10. Patient should have adequate organ function as defined by the following laboratory values: Serum Creatinine = 2.0 × ULN; Serum Bilirubin = 2.0 × ULN; AST and ALT = 3 × ULN. Cf. If the values of liver function tests more than the above-mentioned criteria are related with disease relapse or progression to liver, a patient could be enrolled by investigator’s decision in case of = 5.0 × ULN.
•11. Patients should have archived tumor tissue or fresh tissue sample obtained from re-biopsy at relapse available for targeted sequencing.
•12. In case of written consent to participation in clinical study: Must sign the subject consent form that states the blood sampling done according to the study protocol and that the subject has comprehended the purpose and the necessary procedures of clinical study with intention to participate in the clinical study (or signed by the subject’s representative). (Other sites except Samsun Medical Center : optional)

排除标准

•Patients eligible for this study must not meet any of the following criteria
•1. Patient has history of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan.
•2. Patient has a concurrent malignancy or has had a malignancy in the last 3 years prior to start of study treatment (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
•3. Patient has had major surgery within 21 days prior to starting study drug or has not recovered from major side effects of the surgery
•4. Patient with current use of immunosuppressive medication, EXCEPT for the following: - Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) - Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent - Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). The use of 10 mg or more of prednisolone may be acceptable for adrenal insufficiency according to the investigator’s judgment.
•5. Patient has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication including any of the following: - Left Ventricular Ejection Fraction (LVEF) < 50% as determined by echocardiogram - QTc > 480 msec on screening ECG (using the QTcF formula) - Unstable angina pectoris - Ventricular arrhythmias except for benign premature ventricular contractions - Supraventricular and nodal arrhythmias not controlled with medication - Conduction abnormality requiring a pacemaker - Valvular disease with documented compromise in cardiac function
•6. Patient has known history of testing positive for HIV or known acquired immunodeficiency syndrome
•7. Patient has known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v.5.0 Grade = 3).
•8. Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment contraindicate her participation in the clinical study (e.g. uncontrolled diabetes, chronic pancreatitis, active chronic hepatitis etc.). Other severe acute or chronic medical conditions include colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator. Cf. Persisting toxicity related to prior therapy (NCI CTCAE v.5.0 Grade > 1); however, alopecia, sensory neuropathy Grade = 2, or other Grade = 2 not constituting a safety risk based on investigator’s judgment are acceptable.”
•9. Patient has active infection requiring systemic therapy
•10. Patient has prior organ transplantation including allogenic stem-cell transplantation
•11. Patient has active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. However, patients with diabetes type I, vitiligo, p

研究者

发起方

Samsung Medical Center

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