Early-stage, Extranodal NK-T-Cell Lymphoma, High-Risk Cancer
Conditions
Keywords
NK/T-Cell Lymphoma, Nasal and Nasal-Type, anti-PD-1 antibody, radiotherapy, chemotherapy, Pegaspargase
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 Intermediate/High-Risk extranodal NK/T cell lymphoma
Interventions
DRUGAnti-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
DRUGPegaspargase
3000 IU im on Day 2 of each 14-day cycle for 3 cycles in induction treatment
DRUGGemcitabine
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
DRUGOxaliplatin
85 mg/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
RADIATIONInvolved site radiotherapy
Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50Gy 14-28 days after inductive therapy
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The Affiliated Hospital Of Guizhou Medical University
The First Hospital of Jilin University
People's Hospital of Ningxia Hui Autonomous Region
The First Affiliated Hospital of Dalian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival rate at year 2 after enrollment, 2y-PFS | 2 year | From enrollment to disease progression or any death |
| Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS | 2-year, 5-year | From enrollment to death |
| acute toxicity | From enrollment to 3 months after treatment | evaluated according to the CTCAE criteria |
| Quality of Life，QoL | baseline, 1/3/6/12/24 months after treatment | evaluated according to EORTC-QLQ-HN35 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORShunan Qi, MD
Chinese Academy of Medical Sciences
Outcome results
None listed