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

NCT05149170 | Unknown Phase 2 DMC

• 1 other identifier: CLCG-NKT-2101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

NK/T-Cell Lymphoma, Nasal and Nasal-Type; radiotherapy; Anti-PD-1 Antibody

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Progression-free survival rate at year 2 after enrollment, 2y-PFS

  2-year

• Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS

  2-year, 5-year

• Rate of acute toxicity (any and above grade 3)

  From enrollment to 3 months after treatment

• Quality of Life change, QoL

  baseline, 1/3/6/12/24 months after treatment

• Quality of Life change, QoL

  baseline, 1/3/6/12/24 months after treatment

Other Outcomes (1)

• Biomarkers to predict anti-PD-1 antibody efficacy and 2y-PFS

  baseline

Study Arms (1)

Inductive and concurrent anti-PD-1 antibody combined with radiotherapy

EXPERIMENTAL

All the enrolled patients receive 2 doses of inductive anti-PD-1 antibody (Tislelizumab 200mg) every two weeks, and then Involved-site radiotherapy (50±6-10 Gy) with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.

Drug: Anti-PD-1 monoclonal antibody

Interventions

Anti-PD-1 monoclonal antibody DRUG

inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT

Also known as: radiotherapy

Inductive and concurrent anti-PD-1 antibody combined with radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Peking University Cancer Hospital & Institute: collaborator
• The First Hospital of Jilin University: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

• Li JY, Qi SN, Hu C, Liu X, Yang Y, Wu T, Zheng R, Feng XL, Ni XG, Jin FY, Song YQ, Liu WP, Zhou SY, Li YX. Tislelizumab and radiation therapy in low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type: a phase II study protocol. Future Oncol. 2024 Feb;20(5):245-256. doi: 10.2217/fon-2023-0065. Epub 2023 Nov 29.

  PMID: 38018460 DERIVED

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

spartalizumab; Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ye-Xiong Li, MD

  CAMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shunan Qi, MD

CONTACT

+8610-87788995; medata@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Prof. in the radiation oncology department

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: December 8, 2021
• Study Start: October 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2024
• Last Updated: December 8, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From: 6 months after publication. To: 5 years after publication
• Access Criteria: Will share data with the PIs who had specific study plan in immunotherapy area and biomarker area

Locations

CN (1)