Sintilimab With P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type

NCT ID: NCT04127227

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-09
• Study Completion Date: 2023-10-09

Brief Summary

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)

Conditions

NK/T Cell Lymphoma Nos

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sintilimab With P-GemOx

Sintilimab, 200mg, d1, intravenous drip; pegaspargase, 2000U/m2, d1, intravenous drip; gemcitabine, 1000mg/m2, d1,d8, intravenous drip; oxaliplatin, 130mg/m2, d1, intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive Sintilimab maintenance therapy.

Group Type: EXPERIMENTAL

sintilimab,pegaspargase,gemcitabine,oxaliplatin

Intervention Type: DRUG

All patients enrolled in the study will accept sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimens their first-line therapy.

Patients with CR or PR will receive sintilimab maintenance therapy

Interventions

sintilimab,pegaspargase,gemcitabine,oxaliplatin

All patients enrolled in the study will accept sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimens their first-line therapy.

Patients with CR or PR will receive sintilimab maintenance therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• biopsy proved extranodal natural killer/T-cell lymphoma, nasal type;
• newly diagnosed stage III/IV patients;
• at least one evaluable lesion；
• ECOG PS 0-2;
• 18-75 years; without other malignancy;
• proper functioning of the major organs.

Exclusion Criteria

• hemophagocytic syndrome or aggressive NK cell leukemia;
• involvement of central nervous system;
• previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingqing Cai

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qingqing Cai, MD

Role: CONTACT

caiqq@sysucc.org.cn

0086-20-87342823

Facility Contacts

Liping Ma, MD

Role: primary

References

Tian XP, Cai J, Xia Y, Zhang YC, Wang L, Liu PP, Huang HQ, Li YJ, Zhou H, Li ZM, Yang J, Wei LQ, Zou QH, Huang Y, Li J, Ling L, Zhong WL, Cai QQ. First-line sintilimab with pegaspargase, gemcitabine, and oxaliplatin in advanced extranodal natural killer/T cell lymphoma (SPIRIT): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2024 May;11(5):e336-e344. doi: 10.1016/S2352-3026(24)00066-8. Epub 2024 Mar 27.

Reference Type: DERIVED

PMID: 38554717 (View on PubMed)

Other Identifiers

B2019-148

Identifier Type: -

Identifier Source: org_study_id