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

Primary Purpose

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

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
LEAP regimen
Sponsored by
Rong Tao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type focused on measuring Natural killer/T-cell lymphoma, Sintilimab, Pegaspargase, Anlotinib

Eligibility Criteria

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

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.

Sites / Locations

  • Xinhua HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LEAP Regimen

Arm Description

Pegaspargase, 2500IU/m2, im, day 1 Sintilimab, 200mg, iv day1 Anlotinib, 8mg, oral, day 1-14 The LEAP regimen will be repeated every 3 weeks.

Outcomes

Primary Outcome Measures

Complete response rate
The complete response rate will be assessed on week 24.

Secondary Outcome Measures

Progression free survival
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Overall response rate
The overall response rate will be assessed on Week 24
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Overall survival
Overall survival is defiend as the time from entry onto the treatment until death of any reason

Full Information

First Posted
June 30, 2019
Last Updated
January 27, 2021
Sponsor
Rong Tao
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1. Study Identification

Unique Protocol Identification Number
NCT04004572
Brief Title
Sintilimab, Pegaspargase and Anlotinib for Stage IV Natural Killer /T-cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rong Tao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

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
Keywords
Natural killer/T-cell lymphoma, Sintilimab, Pegaspargase, Anlotinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LEAP Regimen
Arm Type
Experimental
Arm Description
Pegaspargase, 2500IU/m2, im, day 1 Sintilimab, 200mg, iv day1 Anlotinib, 8mg, oral, day 1-14 The LEAP regimen will be repeated every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
LEAP regimen
Other Intervention Name(s)
Pegaspargase, Sintilimab, Anlotinib
Intervention Description
Patients will be given LEAP regimen every 3 weeks for 8 cycles.
Primary Outcome Measure Information:
Title
Complete response rate
Description
The complete response rate will be assessed on week 24.
Time Frame
Week 24 +/-7 days
Secondary Outcome Measure Information:
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 response rate
Description
The overall response rate will be assessed on Week 24
Time Frame
Week 24 +/-7 days
Title
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Description
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Time Frame
Day 1 of each course of chemotherapy and then every 3 months for 1 year
Title
Overall survival
Description
Overall survival is defiend as the time from entry onto the treatment until death of any reason
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Tao, MD., PhD
Phone
+86-21-25077607
Email
hkutao@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Hao Zhang, MD., PhD
Phone
+86-21-25077607
Email
zwh98@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Tao, MD., PhD
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital
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
+86-21-25077603
Email
hkutao@hotmail.com
First Name & Middle Initial & Last Name & Degree
Rong Tao, MD.,PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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