NCT04414969

Anti-PD-1 Antibody Combined With Peg-Asparaginase and Chidamide for the Early Stage of NK/T Cell Lymphoma

Anti-PD-1 Antibody, Peg-Asparaginase, Chidamide Combined With Radiotherapy for the First-line Treatment of Patients With Stage I/II Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL): An Open-label, Multicenter, Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective pilot study to evaluate the efficacy and safety of the anti-PD-1 antibody combine with Peg-asparaginase and Chidamide regimen for stage IE and IIE ENKTL.

Detailed description

Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin's lymphoma and shows extremely poor survival. Several retrospective studies and randomized prospective phase 2 studies have shown that Peg-aspargase based chemotherapy regimens achieved a promising efficacy in the first line treatment of ENKTL. However, about one third of patients will relapse or become refractory after Peg-aspargase-based chemotherapy followed by radiotherapy, and some patients cannot tolerate the toxicities caused by chemotherapy. Anti-PD-1/PD-L1 antibodies and Chidamide are active drugs for the treatment of relapsed/refractory ENKTL. However, there is no prospective study to evaluate the efficacy and safety of anti-PD-1 antibody combine with Peg-asparaginase and Chidamide in the newly diagnosed early stage ENKTL. This prospective pilot study to evaluate the efficacy and safety of the anti-PD-1 antibody combine with Peg-asparaginase and Chidamide regimen for stage IE and IIE ENKTL.

Conditions

• Immune Checkpoint Inhibitor
• Chemotherapy Effect
• Epigenetic Disorder
• NK/T-cell Lymphoma of Nasal Cavity

Interventions

Type	Name	Description
DRUG	Anti-PD-1 antibody+Peg-Asparaginase+Chidamide	Anti-PD-1 antibody 200mg ivdrip d1, PEG-ASP 2500U/m2 im d1, Chidamide, 30mg, po, on d1，d5，d8，d12，d15，d19. The regimen was repeated every 3 weeks for 4 cycles followed by involved-field radiotherapy after got CR and PR (patients with efficacy of SD and PD withdrew from the study). Intensity-modulated radiation treatment was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 54-56 Gy. During the radiotherapy, the anti-PD-1 antibody is administrated (200mg ivdrip, every 3 weeks) for 2 cycles. After the completion of radiotherapy, the subsequent 2 cycles of anti-PD-1 antibody + Peg-Asparaginase + Chidamide are administrated. After the end of all the above induction treatments , anti-PD-1 antibody (200mg ivdrip, every 3 weeks for up to 9 cycles) is given as maintenance therapy for 6 months (the total cycles of anti-PD-1 antibody is 17）.

Timeline

• Start date: 2020-06-26
• Primary completion: 2022-07-01
• Completion: 2025-07-01
• First posted: 2020-06-04
• Last updated: 2020-07-07

Locations

1 site across 1 country: China