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

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

tislelizumab, azacytidine, lenalidomide

tislelizumab, etoposide, pegaspargase

About this trial

This is an interventional treatment trial for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Xinhua Hospital,Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

TALE regimen

TEPA regimen

Arm Description

tislelizumab plus azacytidine and lenalidomide

tislelizumab plus etoposide and pegaspargase

Outcomes

Primary Outcome Measures

Overall response rate

The overall response rate will be assessed on Week 12

Secondary Outcome Measures

Complete response rate

The complete response rate will be assessed on Week 12

Progression free survival

Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.

Overall survival

Overall survival is defined as the time from entry onto the treatment until death of any reason

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

From day 1 of each course of chemotherapy to the 3 months after the last dose of therapy

Full Information

NCT ID

NCT05058755

First Posted

September 17, 2021

Last Updated

September 17, 2021

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05058755

Brief Title

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

Official Title

Efficacy and Safety of Tislelizumab Combined Treatment in Refractory Natural Killer/T-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 17, 2021 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

About 20-30% of early-stage patients and 40-60% of late-stage NKTCL patients will experience disease relapse and refractory disease, and the median survival time of relapsed patients is about 6 months. PD-1 antibody is an effective drug for the treatment of patients with relapsed/refractory NKTCL, but the response rate and complete remission rate of monotherapy are low. How to improve the prognosis of patients is an important way to try combination therapy. In this study, we aim to explore the effectiveness and safety of a novel anti-PD-1 antibody, tislelizumab, in combination with different drugs (tislelizumab plus azacytidine and lenalidomide, or tislelizumab plus etoposide and pegaspargase) to treat refractory NK/T.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TALE regimen

Arm Type

Experimental

Arm Description

tislelizumab plus azacytidine and lenalidomide

Arm Title

TEPA regimen

Arm Type

Experimental

Arm Description

tislelizumab plus etoposide and pegaspargase

Intervention Type

Drug

Intervention Name(s)

tislelizumab, azacytidine, lenalidomide

Other Intervention Name(s)

Tileilizhu Dankang

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

tislelizumab, etoposide, pegaspargase

Other Intervention Name(s)

Tileilizhu Dankang

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall response rate

Description

The overall response rate will be assessed on Week 12

Time Frame

Week 12 +/-7 days

Secondary Outcome Measure Information:

Title

Complete response rate

Description

The complete response rate will be assessed on Week 12

Time Frame

Week 12 +/-7 days

Title

Progression free survival

Description

Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.

Time Frame

1-year

Title

Overall survival

Description

Overall survival is defined as the time from entry onto the treatment until death of any reason

Time Frame

1-year

Title

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

Description

From day 1 of each course of chemotherapy to the 3 months after the last dose of therapy

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rong Tao, MD

Phone

0086-21-25077604

hkutao@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chuanxu Liu, MD

Phone

0086-21-25077605

linchuanxu@xinhuamed.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rong Tao, MD

Organizational Affiliation

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xinhua Hospital,Shanghai Jiao Tong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200092

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rong Tao, MD

Phone

0086-21-25077604

hkutao@hotmail.com

First Name & Middle Initial & Last Name & Degree

Chuanxu Liu, MD

Phone

0086-21-25077605

liuchuanxu@xinhuamed.com.cn

First Name & Middle Initial & Last Name & Degree

Chuanxu Liu, MD

First Name & Middle Initial & Last Name & Degree

Rong Tao, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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