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

High-Risk Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254899
• Other study ID #: CLCG-NKT-2102
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Shunan M Qi
• Phone: +861087788995
• 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• 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-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

Related Conditions & MeSH terms

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

Intervention

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
• Pegaspargase
3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment
• Gemcitabine
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
• 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

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Beijing Cancer Hospital, First Affiliated Hospital of Jilin University, The Affiliated Hospital Of Guizhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	biomarkers (single cell transcriptomics)		baseline, 2 years
Primary	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	At the end of Cycle 3 (each cycle is 14 days)
Secondary	Progression-free survival rate at year 2 after enrollment, 2y-PFS	From enrollment to disease progression or any 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	acute toxicity	evaluated according to the CTCAE criteria	From enrollment to 3 months after treatment
Secondary	Quality of Life,QoL	evaluated according to EORTC-QLQ-HN35	baseline, 1/3/6/12/24 months after treatment
Secondary	Quality of Life,QoL	evaluated according to EORTC-QLQ-C30	baseline, 1/3/6/12/24 months after treatment