Tislelizumab Combined Treatment in Refractory Extranodal NK/T-cell Lymphoma

NCT05058755 | Completed

• 1 other identifier: XHLSG-NK-1903
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Natural killer/T-cell lymphoma (NKTCL) patients with relapsed/refractory disease had very poor outcome. Anti-PD-1 antibody showed promising results in response, but but the complete remission rate of was low. Some anti-PD-1 antibody based regimen showed higher and deeper response in NKTCL patients.

Conditions

Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  The overall response rate will be assessed on Week 12

  Week 12 +/-7 days

Secondary Outcomes (4)

• Complete response rate

  Week 12 +/-7 days

• Progression free survival

  1-year

• Overall survival

  1-year

• Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v5.0.

Study Arms (2)

TALE regimen

EXPERIMENTAL

tislelizumab plus azacytidine and lenalidomide

Drug: tislelizumab, azacytidine, lenalidomide

TEPA regimen

EXPERIMENTAL

tislelizumab plus etoposide and pegaspargase

Drug: tislelizumab, etoposide, pegaspargase

Interventions

tislelizumab, azacytidine, lenalidomide DRUG

tislelizumab, 200mg, iv, day 1, every 21 days. azacytidine, 75mg/m2, ih, days 1-7, every 21 days. lenalidomide, 25mg, po, days 1-14, every 21 days.

Also known as: Tileilizhu Dankang

TALE regimen

tislelizumab, etoposide, pegaspargase DRUG

tislelizumab, 200mg, iv, day 1, every 21 days. etoposide, 100mg, iv, days 1-3, every 21 days. pegaspargase, 2000U/m2, day 1, every 21 days

Also known as: Tileilizhu Dankang

TEPA regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with biopsy histopathology, immunohistochemistry and EBER test meet ing the WHO 2016 diagnostic criteria for NK/T cell lymphoma.
• With progressive disease after asparaginase-based combined chemotherapy
• Have experienced multiple courses of PD-1/PD-L1 treatment with non-responsive or progressive disease.
• PET/CT or CT/MRI with at least one measurable lesion or objectively evaluable lesion.
• General ECOG score 0-3 points.
• The laboratory examination within 1 week before enrollment meets the following conditions:
• Blood routine: Hb\>80g/L, PLT\>50×109/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Blood coagulation test: plasma fibrinogen ≥1.0g/L. Heart function: LVEF≥50%, ECG did not indicate any acute myocardial infarction, arrhythmia, or atrioventricular block of degree I or more.
• Signed informed consent form.
• Voluntarily comply with research protocols, follow-up plans, laboratory and auxiliary examinations.

You may not qualify if:

• Patients with a history of pancreatitis (only patients who are planning to undergo PD1 combined with pegaspargase are excluded).
• Severe infections require ICU treatment.
• Combined HCV or HIV infection. Patients with HBV infection who receive antiviral treatment at the same time will not be excluded.
• There are serious complications such as fulminant DIC.
• Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade ≥2, decompensated liver or kidney insufficiency, hypertension and diabetes that cannot be controlled despite active treatment, nearly 6 years old There were cardio-cerebrovascular thrombotic or hemorrhagic events within months.
• Pregnant and lactating women.
• Have a history of autoimmune diseases, have disease activity in the past 6 months, and are still receiving oral immunosuppressive therapy within the past three months, and the daily dose of oral prednisone is greater than 10 mg.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Interventions

tislelizumab; Azacitidine; Lenalidomide; Etoposide; pegaspargase

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Rong Tao, MD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: September 17, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)