Anti-PD-1 Antibody Combined With Peg-Asparaginase and Chidamide for the Early Stage of NK/T Cell Lymphoma

STATUS

Recruiting
End date

Jul 1, 2025
participants needed

35
sponsor

Hunan Cancer Hospital

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Updated on 19 February 2024

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cancer

ct scan

glucocorticoids

renal function

measurable disease

neutrophil count

positron emission tomography

peg-asparaginase

serum bilirubin

electrocardiogram

cancer therapy

biological therapy

hepatitis c

frontal sinus

Summary

This prospective pilot study to evaluate the efficacy and safety of the anti-PD-1 antibody combine with Peg-asparaginase and Chidamide regimen for stage IE and IIE ENKTL.

Description

Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin's lymphoma and shows extremely poor survival. Several retrospective studies and randomized prospective phase 2 studies have shown that Peg-aspargase based chemotherapy regimens achieved a promising efficacy in the first line treatment of ENKTL. However, about one third of patients will relapse or become refractory after Peg-aspargase-based chemotherapy followed by radiotherapy, and some patients cannot tolerate the toxicities caused by chemotherapy. Anti-PD-1/PD-L1 antibodies and Chidamide are active drugs for the treatment of relapsed/refractory ENKTL. However, there is no prospective study to evaluate the efficacy and safety of anti-PD-1 antibody combine with Peg-asparaginase and Chidamide in the newly diagnosed early stage ENKTL. This prospective pilot study to evaluate the efficacy and safety of the anti-PD-1 antibody combine with Peg-asparaginase and Chidamide regimen for stage IE and IIE ENKTL.

Details

Condition	Chemotherapy Effect, Epigenetic Disorder, Immune Checkpoint Inhibitor, NK/T-cell Lymphoma of Nasal Cavity
Age	18-75 years
Treatment	Anti-PD-1 antibody+Peg-Asparaginase+Chidamide
Clinical Study Identifier	NCT04414969
Sponsor	Hunan Cancer Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Pathologically confirmed, previously untreated ENKTL with stage I/II (for stage I, the patients should have one or more of the following risk factors: Extensive local invasion and or bone destruction: invasion of the inner orbital wall or bottom wall, orbital apex, orbital contents, maxillary sinus, sphenoid sinus, frontal sinus or ethmoid sinus invasion, hard palate, ethmoid plate, nasopharynx, slope bone is invaded. Skin invasion: nose and or cheek skin invasion; Waldeyer's ring invasion; LDH>upper limit of normal; EBV-DNA > upper limit of normal; B symptoms)
	Age range from 18 to 75 years
	Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
	At least one evaluable or measurable lesion complying with Lugano 2014 Standard (evaluable lesion: the examination show increased uptake of lymph nodes or extranodal areas (higher than that of the liver) by 18F-Fluorodeoxyglucose/Positron Emission Tomography (18FDG/PET) and the PET and/or Computed Tomography (CT) features coincide with lymphoma characteristics; measurable lesion: nodal lesions were longer than 15 mm or extranodal lesions were longer than 10 mm, and accompanied by increased 18FDG uptake). Increased liver or spleen diffuse 18FDG uptake without measurable lesions should be excluded
	Adequate haematologic function (haemoglobin 90 g/l, absolute neutrophil count 1500/ml, platelets 8010e9/l)
	Adequate hepatic function (total serum bilirubin 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase 2.5 times the upper limit of normal)
	Hepatitis B virus carriers should have HBV-DNA <10e4 copies and should use antiviral drugs
	Adequate renal function (serum creatinine 1.5 mg/dl, creatinine clearance 50 ml/min)
	Normal coagulation function and electrocardiogram results
	No previous anti-cancer treatment including chemotherapy, radiotherapy, immunotherapy, biological therapy, glucocorticoids therapy for lymphoma
	Willingness to provide written informed consent
Exclusion Criteria
	History of other malignancy within the past 5 years (except for basal cell carcinoma of the skin and carcinoma in situ of the cervix)
	With clinically diagnosed hemophagocytic syndrome (HPS); or aggressive NK cell leukemia; or central nervous system invasion
	Previous treatments with immune checkpoint inhibitor, including nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, ipilimumab, sintilimab, etc
	Previous treatments with HDAC inhibitor, including Chidamide, romidepsin, panobinostat, belinostat, etc
	Patients allergic of any of drug in this regimen
	Pregnant or lactating women
	Participated in other clinical trials within the 4 weeks prior to enrollment
	History of severe hemorrhage, or any bleeding events with a severe grade of 3 or more in CTCAE 5.0 within 4 weeks prior to enrollment
	Blood pressure unable to be controlled ideally with single antihypertensive drug therapy (Systolic blood pressure > 140 mmHg, Diastolic Blood Pressure > 90 mmHg); Clinically significant cardiovascular disease (e.g. activity) including history of CVA (within 6 months), myocardial infarction (within 6 months), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure; serious cardiac arrhythmia beyond drug control or potentially affecting experimental therapy
	The subject is being treated with immunosuppressive agents, glucocorticoids systemic or absorbable local usingfor immunosuppression purposes (dose> 10 mg / day prednisone or other therapeutic glucocorticoids) within two weeks before enrollment the study
	Abnormal coagulation or bleeding tendency (It must be satisfied that INR is under normal range without anticoagulant within 14 days prior to signing informed consent); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; on the premise that the international standardized ratio of prothrombin time (INR) is less than 1.5, small doses of warfarin (1 mg po, qd) or aspirin (no more than 100 mg qd) are allowed for preventive purposes
	Arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to precancerous chemotherapy is excluded if it has been cured judged by the researchers) and pulmonary embolism
	Suffered major surgery within 42 days prior to enrollment
	Have an active autoimmune disease that requires systemic treatment within the past two years
	Severe or uncontrolled infections, except fever associated with lymphoma B symptoms
	History of psychotropic drug abuse and unable to get rid of or with mental disorders
	History of immunodeficiency, including HIV positive testing, or other acquired, congenital immunodeficiency disorders, or organ transplantation history
	Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

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Anti-PD-1 Antibody Combined With Peg-Asparaginase and Chidamide for the Early Stage of NK/T Cell Lymphoma