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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
• Intervention / Treatment: Drug: CAPA indution immunotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rong Tao, MD; Phone Number: 008621-25077603; Email: hkutao@hotmail.com
• Study Contact Backup: Name: Chuanxu Liu, MD; Phone Number: 008621-25077607; Email: liuchuanxu@xinhuamed.com.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University
      • Contact: Zhiming Li, MD; Phone Number: 0086-020-87343765; Email: lizhm@sysucc.org.cn
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Eye Ear Nose and Throat Hospital, Fudan University
      • Contact: Hao Ding, MD; Phone Number: +86-21-64377134; Email: eentding@163.com
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Department of Hematology, Xinhua hospital
      • Contact: Chuanxu Li, MD; Phone Number: 008621-25077607; Email: liuchuanxu@xinhuamed.com.cn
      • Principal Investigator: Rong Tao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CAPA indution immunotherapy; CAPA regimen, repeat every 3 week for 4 cycles.	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.; Other Names: Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of overall survival at 2 years	overall survival rate (OS) of patients at 2 years	2 years
Rate of progression free survival at 2 years	progression free survival rate (PFS) of patients at 2 years	2 years
percent of adverse events	adverse events graded by NCI CTCAE Ver4.03	2 years

Collaborators and Investigators

• Sponsor: Rong Tao
• Investigators: Principal Investigator: Rong Tao, MD, Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2020
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: April 25, 2020
• First Submitted That Met QC Criteria: April 25, 2020
• First Posted (ACTUAL): April 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: radiotherapy; apatinib; camrelizumab; pegaspargase; natural killer/T-cell lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: XHLSG-NK-1902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No