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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04366128
• Other study ID #: XHLSG-NK-1902
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Rong Tao, MD
• Phone: 008621-25077603
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• CAPA indution immunotherapy
Camelirumab 200mg Intravenous injection on day 1. Apatinib 250mg taken orally once daily. Pegaspargase 2000U/m2 Intramuscular injection on day 1.

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong
China	Department of Hematology, Xinhua hospital	Shanghai	Shanghai
China	Shanghai Eye Ear Nose and Throat Hospital, Fudan University	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	Rate of complete response at week 24	Rate of patients with complete response (CR) at week 24 evaluate by Lugano 2014 criteria	24 weeks
Secondary	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	24 weeks
Secondary	Rate of overall survival at 2 years	overall survival rate (OS) of patients at 2 years	2 years
Secondary	Rate of progression free survival at 2 years	progression free survival rate (PFS) of patients at 2 years	2 years
Secondary	percent of adverse events	adverse events graded by NCI CTCAE Ver4.03	2 years