Sintilimab, Pegaspargase and Anlotinib for Stage IV Natural Killer /T-cell Lymphoma

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

Official title:

A Multi-center, Prospective Study of the Efficacy and Safety of PD-1 Antibody (Sintilimab) in Combination With Pegaspargase and Erlotinib in the Treatment of Stage IV Extranodal NK/T-cell Lymphoma Unfit for High-intensity Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04004572
• Other study ID #: XHLSG-NK-1901
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Rong Tao, MD., PhD
• Phone: +86-21-25077607
• Email: hkutao[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.

Description:

Stage IV NK/T-cell lymphoma has a poor prognosis, and autologous hematopoietic stem cell transplantation can improve the prognosis of patients who have achieved remission after chemotherapy. The median survival time for patients who were not suitable for transplantation was about 1 year. Asparaginase is the backbone drug for the treatment of NK/T-cell lymphoma. PD-1 antibody is effective for relapsed/refractory NK/T-cell lymphoma. Our previous study found that anlotinib is active in relapsed/refractory NK/T Cell lymphoma. This study is aimed to investigate the efficacy and safety of Sintilimab, a PD-1 antibody approved in China, in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria.

• Stage IV disease according Lugano 2014 staging system. Newly diagnosed patients, or relapsed disease without a history of asparaginase-containing regimen.

• PET/CT or CT/MRI with at least one objectively evaluable lesion.

• The age is greater than 65 years old. Those who are younger than 65 years should have a documented history unfit for high-dose combination chemotherapy (ie. high doses of methotrexate or high doses of dexamethasone, or autologous hematopoietic stem cell transplantation).

• General status ECOG score 0-3 points.

• The laboratory test 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. Coagulation : plasma fibrinogen = 1.0g / L. Cardiac function: LVEF=50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.

• Sign the informed consent form.

• Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.

Exclusion Criteria:

• Patients with a history of pancreatitis.

• Active infection requires ICU treatment.

• Concomitant HCV or HIV infection. Patients who are infected with HBV at the same time are not excluded.

• Serious complications such as fulminant DIC.

• Significant organ dysfunction: such as respiratory failure, NYHA classification = 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months.

• Pregnant and lactating women.

• Had a history of autoimmune diseases, and disease was active in the last 6 months, and was still taking oral immunosuppression in the past three months.

For the treatment, the daily dose of oral prednisone is greater than 10 mg.

• Those who were known to be allergic to drugs in the study regimen.

• Patients with other tumors who require surgery or chemotherapy within 6 months.

• Other experimental drugs are being used.

Related Conditions & MeSH terms

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

Intervention

Drug:
• LEAP regimen
Patients will be given LEAP regimen every 3 weeks for 8 cycles.

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Rong Tao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate	The complete response rate will be assessed on week 24.	Week 24 +/-7 days
Secondary	Progression free survival	Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.	1-year
Secondary	Overall response rate	The overall response rate will be assessed on Week 24	Week 24 +/-7 days
Secondary	Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.	Day 1 of each course of chemotherapy and then every 3 months for 1 year
Secondary	Overall survival	Overall survival is defiend as the time from entry onto the treatment until death of any reason	1-year