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

NCT05254899 | Unknown Phase 2 DMC

• 1 other identifier: CLCG-NKT-2102
• Study Type: interventional
• Target: 54
• 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 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 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

• acute toxicity

  From enrollment to 3 months after treatment

• Quality of Life，QoL

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

• Quality of Life，QoL

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

Other Outcomes (1)

• biomarkers (single cell transcriptomics)

  baseline, 2 years

Study Arms (1)

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

EXPERIMENTAL

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; Drug: Pegaspargase; Drug: Gemcitabine; Drug: Oxaliplatin; Radiation: Involved site radiotherapy

Interventions

Anti-PD-1 monoclonal antibody DRUG

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

Also known as: Tislelizumab

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

Pegaspargase DRUG

3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment

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

Gemcitabine DRUG

1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment

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

Oxaliplatin DRUG

1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment

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

Involved site radiotherapy RADIATION

Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy

Inductive and concurrent anti-PD-1 antibody combined with chemo-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-II
• Have at lest one following risk factor: Elevated serum LDH level; PTI+; stage II
• 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 Affiliated Hospital Of Guizhou Medical University: collaborator
• The First Hospital of Jilin University: collaborator

Study Sites (1)

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

spartalizumab; tislelizumab; pegaspargase; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Shunan M Qi, MD

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shunan M Qi

CONTACT

+861087788995; 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 7, 2021
• First Posted: February 24, 2022
• Study Start: October 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2024
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

CN (1)