Back to resultsAnti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL
Primary Purpose
Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type, Early-stage, High-Risk Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anti-PD-1 monoclonal antibody
Pegaspargase
Gemcitabine
Oxaliplatin
Involved site radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type focused on measuring NK/T-Cell Lymphoma, Nasal and Nasal-Type, anti-PD-1 antibody, radiotherapy, chemotherapy, Pegaspargase
Eligibility Criteria
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
Sites / Locations
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Complete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy
To evaluate the complete response (CR) rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy according to Lyric 2016 criteria
Secondary Outcome Measures
Progression-free survival rate at year 2 after enrollment, 2y-PFS
From enrollment to disease progression or any death
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
From enrollment to death
acute toxicity
evaluated according to the CTCAE criteria
Quality of Life，QoL
evaluated according to EORTC-QLQ-HN35
Quality of Life，QoL
evaluated according to EORTC-QLQ-C30
Full Information
NCT ID
NCT05254899
First Posted
November 7, 2021
Last Updated
February 23, 2022
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Peking University Cancer Hospital & Institute, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT05254899
Brief Title
Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Peking University Cancer Hospital & Institute, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type, Early-stage, High-Risk Cancer
Keywords
NK/T-Cell Lymphoma, Nasal and Nasal-Type, anti-PD-1 antibody, radiotherapy, chemotherapy, Pegaspargase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Anti-PD-1 monoclonal antibody
Other Intervention Name(s)
Tislelizumab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Intervention Description
3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Intervention Type
Radiation
Intervention Name(s)
Involved site radiotherapy
Intervention Description
Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy
Primary Outcome Measure Information:
Title
Complete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy
Description
To evaluate the complete response (CR) rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy according to Lyric 2016 criteria
Time Frame
At the end of Cycle 3 (each cycle is 14 days)
Secondary Outcome Measure Information:
Title
Progression-free survival rate at year 2 after enrollment, 2y-PFS
Description
From enrollment to disease progression or any death
Time Frame
2 year
Title
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
Description
From enrollment to death
Time Frame
2-year, 5-year
Title
acute toxicity
Description
evaluated according to the CTCAE criteria
Time Frame
From enrollment to 3 months after treatment
Title
Quality of Life，QoL
Description
evaluated according to EORTC-QLQ-HN35
Time Frame
baseline, 1/3/6/12/24 months after treatment
Title
Quality of Life，QoL
Description
evaluated according to EORTC-QLQ-C30
Time Frame
baseline, 1/3/6/12/24 months after treatment
Other Pre-specified Outcome Measures:
Title
biomarkers (single cell transcriptomics)
Time Frame
baseline, 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shunan M Qi
Phone
+861087788995
Email
medata@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shunan M Qi, MD
Organizational Affiliation
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunan M Qi, MD
Phone
+861087788995
Email
medata@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL
We'll reach out to this number within 24 hrs