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Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE ENKTL

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CAPA indution immunotherapy

About this trial

This is an interventional treatment trial for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type focused on measuring camrelizumab, apatinib, pegaspargase, radiotherapy, natural killer/T-cell lymphoma

Eligibility Criteria

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

Inclusion Criteria:

Patients who meet the WHO 2016 diagnostic criteria for NK/T-cell lymphoma by biopsy histopathology, immunohistochemistry and EBER.
The primary site is in the nasal cavity or upper gastrointestinal tract. The de novo diagnosed patient has at least one objective and evaluable lesion.
Stage IE / IIE disease according to Lugano 2014 lymphoma staging system.
ECOG score 0-3.
The laboratory examination within 1 week before entering the group meets the following conditions:
1. Blood routine test: neutrophil count≥1.0 × 10^9/L, Hemoglobin≥80g/L, Platelet≥50 × 10^9/L.
2. Coagulation routine: plasma fibrinogen ≥ 1.0g / L.
3. Liver function: Alanine aminotransferase, aspartate aminotransferase and total bilirubin ≤ 2 times the upper limit of normal value.
4. Renal function: Creatinine is normal.
5. Refers to oxygen saturation> 93%.
6. Cardiac function: Left ventricular ejection fraction ≥50%, electrocardiogram does not suggest any acute myocardial infarction, arrhythmia or atrioventricular block above 1 degree
Signed informed consent.
Voluntarily follow the research protocol, follow-up plan, laboratory and auxiliary examinations.

Exclusion Criteria:

accompanied with HCV or HIV infection, HBV-infected patients who also receive antiviral treatment are not excluded.
Severe infection requires ICU treatment.
Serious complications such as hemophagocytic syndrome, DIC, etc.
Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade ≥3, decompensated liver or kidney dysfunction, hypertension and diabetes that cannot be controlled despite active treatment.
Have a history of autoimmune diseases, have disease activity in the last 6 months, and are still taking oral immunosuppressive therapy within the past three months, with a daily dose of oral prednisone greater than 10 mg.
Pregnant and lactating women.
Those who are known to be allergic to drugs in the CAPA regimen.
Patients with other tumors who need surgery or chemotherapy within 6 months.
Other experimental drugs are being used.
The investigators believe that other clinical conditions (including medical history or the presence of comorbidities) of the patient will significantly increase the risk of the subject when using the study treatment drugs.

Sites / Locations

Sun Yat-sen UniversityRecruiting
Shanghai Eye Ear Nose and Throat Hospital, Fudan UniversityRecruiting
Department of Hematology, Xinhua hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAPA indution immunotherapy

Arm Description

CAPA regimen, repeat every 3 week for 4 cycles.

Outcomes

Primary Outcome Measures

Rate of complete response at week 24

Rate of patients with complete response (CR) at week 24 evaluate by Lugano 2014 criteria

Secondary Outcome Measures

Rate of overall response rate at week 24

Rate of patients with complete response and partial response (ORR) at week 24 evaluate by Lugano 2014 criteria

Rate of overall survival at 2 years

overall survival rate (OS) of patients at 2 years

Rate of progression free survival at 2 years

progression free survival rate (PFS) of patients at 2 years

percent of adverse events

adverse events graded by NCI CTCAE Ver4.03

Full Information

NCT ID

NCT04366128

First Posted

April 25, 2020

Last Updated

September 13, 2021

Sponsor

Rong Tao

1. Study Identification

Unique Protocol Identification Number

NCT04366128

Brief Title

Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE ENKTL

Official Title

Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE Natural Killer /T-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

April 25, 2020 (Actual)

Primary Completion Date

December 30, 2021 (Anticipated)

Study Completion Date

December 30, 2023 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of camrelizumab, apatinib, pegaspargase (CAPA) and as an intruction immunotherapy with radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.

Detailed Description

Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with four cycles CAPA induction immunotherapy, followed by 50-56Gy radiotherapy as an approach for stage IE/IIE ENKTCL. The efficacy and safety of this treatment will be measured.

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

camrelizumab, apatinib, pegaspargase, radiotherapy, natural killer/T-cell lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Camrelizumab, apatinib and pegaspargase

Masking

None (Open Label)

Masking Description

Camrelizumab, apatinib and pegaspargase indution immunotherapy

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CAPA indution immunotherapy

Arm Type

Experimental

Arm Description

CAPA regimen, repeat every 3 week for 4 cycles.

Intervention Type

Drug

Intervention Name(s)

CAPA indution immunotherapy

Other Intervention Name(s)

Radiotherapy

Intervention Description

Camelirumab 200mg Intravenous injection on day 1. Apatinib 250mg taken orally once daily. Pegaspargase 2000U/m2 Intramuscular injection on day 1.

Primary Outcome Measure Information:

Title

Rate of complete response at week 24

Description

Rate of patients with complete response (CR) at week 24 evaluate by Lugano 2014 criteria

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Rate of overall response rate at week 24

Description

Rate of patients with complete response and partial response (ORR) at week 24 evaluate by Lugano 2014 criteria

Time Frame

24 weeks

Title

Rate of overall survival at 2 years

Description

overall survival rate (OS) of patients at 2 years

Time Frame

2 years

Title

Rate of progression free survival at 2 years

Description

progression free survival rate (PFS) of patients at 2 years

Time Frame

2 years

Title

percent of adverse events

Description

adverse events graded by NCI CTCAE Ver4.03

Time Frame

2 years

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 who meet the WHO 2016 diagnostic criteria for NK/T-cell lymphoma by biopsy histopathology, immunohistochemistry and EBER. The primary site is in the nasal cavity or upper gastrointestinal tract. The de novo diagnosed patient has at least one objective and evaluable lesion. Stage IE / IIE disease according to Lugano 2014 lymphoma staging system. ECOG score 0-3. The laboratory examination within 1 week before entering the group meets the following conditions: Blood routine test: neutrophil count≥1.0 × 10^9/L, Hemoglobin≥80g/L, Platelet≥50 × 10^9/L. Coagulation routine: plasma fibrinogen ≥ 1.0g / L. Liver function: Alanine aminotransferase, aspartate aminotransferase and total bilirubin ≤ 2 times the upper limit of normal value. Renal function: Creatinine is normal. Refers to oxygen saturation> 93%. Cardiac function: Left ventricular ejection fraction ≥50%, electrocardiogram does not suggest any acute myocardial infarction, arrhythmia or atrioventricular block above 1 degree Signed informed consent. Voluntarily follow the research protocol, follow-up plan, laboratory and auxiliary examinations. Exclusion Criteria: accompanied with HCV or HIV infection, HBV-infected patients who also receive antiviral treatment are not excluded. Severe infection requires ICU treatment. Serious complications such as hemophagocytic syndrome, DIC, etc. Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade ≥3, decompensated liver or kidney dysfunction, hypertension and diabetes that cannot be controlled despite active treatment. Have a history of autoimmune diseases, have disease activity in the last 6 months, and are still taking oral immunosuppressive therapy within the past three months, with a daily dose of oral prednisone greater than 10 mg. Pregnant and lactating women. Those who are known to be allergic to drugs in the CAPA regimen. Patients with other tumors who need surgery or chemotherapy within 6 months. Other experimental drugs are being used. The investigators believe that other clinical conditions (including medical history or the presence of comorbidities) of the patient will significantly increase the risk of the subject when using the study treatment drugs.

Central Contact Person:

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

Rong Tao, MD

Phone

008621-25077603

hkutao@hotmail.com

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

Chuanxu Liu, MD

Phone

008621-25077607

liuchuanxu@xinhuamed.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rong Tao, MD

Organizational Affiliation

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhiming Li, MD

Phone

0086-020-87343765

lizhm@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Zhiming Li, MD

Facility Name

Shanghai Eye Ear Nose and Throat Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hao Ding, MD

Phone

+86-21-64377134

eentding@163.com

Facility Name

Department of Hematology, 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

Chuanxu Li, MD

Phone

008621-25077607

liuchuanxu@xinhuamed.com.cn

First Name & Middle Initial & Last Name & Degree

Rong Tao, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE ENKTL

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