Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL

February 23, 2022 updated by: Shunan Qi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study

The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of inductive Anti-PD-1+P-GEMOX treatment followed by radiotherapy and concurrent Anti-PD-1 antibody in early-stage high-risk extranodal NK/T cell lymphoma, nasal type

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Biopsy proved extranodal NK/T cell lymphoma
  • No previous anti-cancer treatment
  • Measurable lesion on baseline PET/CT and MRI
  • Stage I-II
  • Have at lest one following risk factor: Elevated serum LDH level; PTI+; stage II
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy
All the enrolled patients receive 3 cycles of anti-PD-1 antibody (Tislelizumab 200mg d1) + P-GEMOX (Pegaspargase 3000u d2, Gemcitabine 1g/m2 d2, Oxaliplatin 85mg/m2 d2) systemic treatment every 14 days, followed by involved-site radiotherapy with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.
Drug: Anti-PD-1 monoclonal antibody
200mg iv on Day 1 of each 14-day cycle for 3 cycles in induction treatment; 200mg iv on Day 1,15, 29 during RT treatment
Other Names:
  • Tislelizumab
Drug: Pegaspargase
3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Drug: Gemcitabine
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Drug: Oxaliplatin
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Radiation: Involved site radiotherapy
Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy
Time Frame: At the end of Cycle 3 (each cycle is 14 days)
To evaluate the complete response (CR) rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy according to Lyric 2016 criteria
At the end of Cycle 3 (each cycle is 14 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival rate at year 2 after enrollment, 2y-PFS
Time Frame: 2 year
From enrollment to disease progression or any death
2 year
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
Time Frame: 2-year, 5-year
From enrollment to death
2-year, 5-year
acute toxicity
Time Frame: From enrollment to 3 months after treatment
evaluated according to the CTCAE criteria
From enrollment to 3 months after treatment
Quality of Life，QoL
Time Frame: baseline, 1/3/6/12/24 months after treatment
evaluated according to EORTC-QLQ-HN35
baseline, 1/3/6/12/24 months after treatment
Quality of Life，QoL
Time Frame: baseline, 1/3/6/12/24 months after treatment
evaluated according to EORTC-QLQ-C30
baseline, 1/3/6/12/24 months after treatment

Other Outcome Measures

Outcome Measure
Time Frame
biomarkers (single cell transcriptomics)
Time Frame: baseline, 2 years
baseline, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Peking University Cancer Hospital & Institute
The Affiliated Hospital Of Guizhou Medical University
First Affiliated Hospital of Jilin University

Investigators

  • Principal Investigator: Shunan M Qi, MD, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

November 7, 2021

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCG-NKT-2102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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