Radiotherapy and Anti-PD-1 in Low-risk ES-ENKTCL

Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type Clinical Trial

Official title:

Radiotherapy With Inductive and Concurrent Anti-PD-1 Antibody in Early-stage Low-risk Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05149170
• Other study ID #: CLCG-NKT-2101
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2021
• Source: Chinese Academy of Medical Sciences
• Contact: Shunan Qi, MD
• Phone: +8610-87788995
• Email: medata[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of adding Anti-PD-1 antibody in an inductive and concurrent way to radiotherapy in early-stage low-risk extranodal NK/T cell lymphoma, nasal type

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Biopsy proved extranodal NK/T cell lymphoma

• No previous anti-cancer treatment

• Measurable lesion on baseline PET/CT and MRI

• Stage I

• Normal serum LDH level

• Primary tumor invasion (PTI) absence

• ECOG PS 0-1

• Sufficient organ functions

Exclusion Criteria:

• Other mature T- or NK- lymphoma

• Hemophagocytic lymphohistiocytosis

• Primary CNS lymphoma or CNS-involved lymphoma

• History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment

Related Conditions & MeSH terms

• Early-stage
• Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• Anti-PD-1 monoclonal antibody
inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT

Locations

Country	Name	City	State
China	National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Beijing Cancer Hospital, First Affiliated Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers to predict anti-PD-1 antibody efficacy and 2y-PFS	potential biomarkers in baseline tumor samples and blood samples	baseline
Primary	Rate of Complete response after inductive therapy	complete resolution of disease in imaging and biopsy after inductive therapy	2-4 weeks after inductive anti-PD-1 antibody
Secondary	Progression-free survival rate at year 2 after enrollment, 2y-PFS	From enrollment to any disease progression or death	2-year
Secondary	Overall Survival rate at year 2/5 after enrollment,2y-/5y-OS	From enrollment to death	2-year, 5-year
Secondary	Rate of acute toxicity (any and above grade 3)	toxicities according to CTCAE criteria	From enrollment to 3 months after treatment
Secondary	Quality of Life change, QoL	measurement basing on EORTC-QLQ-HN35 tables	baseline, 1/3/6/12/24 months after treatment
Secondary	Quality of Life change, QoL	measurement basing on EORTC-QLQ-C30 tables	baseline, 1/3/6/12/24 months after treatment