- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05058755
Tislelizumab Combined Treatment in Refractory Extranodal NK/T-cell Lymphoma
Efficacy and Safety of Tislelizumab Combined Treatment in Refractory Natural Killer/T-cell Lymphoma
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rong Tao, MD
- Phone Number: 0086-21-25077604
- Email: hkutao@hotmail.com
Study Contact Backup
- Name: Chuanxu Liu, MD
- Phone Number: 0086-21-25077605
- Email: linchuanxu@xinhuamed.com.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200092
- Xinhua Hospital,Shanghai Jiao Tong University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TALE regimen
tislelizumab plus azacytidine and lenalidomide
|
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.
Other Names:
|
Experimental: TEPA regimen
tislelizumab plus etoposide and pegaspargase
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: Week 12 +/-7 days
|
The overall response rate will be assessed on Week 12
|
Week 12 +/-7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: 1-year
|
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
|
1-year
|
Complete response rate
Time Frame: Week 12 +/-7 days
|
The complete response rate will be assessed on Week 12
|
Week 12 +/-7 days
|
Overall survival
Time Frame: 1-year
|
Overall survival is defined as the time from entry onto the treatment until death of any reason
|
1-year
|
Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time Frame: Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v5.0.
|
From day 1 of each course of chemotherapy to the 3 months after the last dose of therapy
|
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v5.0.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rong Tao, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Etoposide
- Lenalidomide
- Azacitidine
- Pegaspargase
- Tislelizumab
Other Study ID Numbers
- XHLSG-NK-1903
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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