NCT05316246

Efficacy and Safety of BV With Tislelizumab for the Treatment of CD30+ Relapsed/Refractory NK/T-cell Lymphoma

Efficacy and Safety of Brentuximab Vedotin in Combination With Tislelizumab for the Treatment of CD30-positive Relapsed/Refractory NK/T-cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, multicenter, phase 2 study designed to evaluate the efficacy and safety of brentuximab vedotin combined with PD-1 inhibitor tislelizumab in Chinese patients with relapsed/refractory CD30+ NK/CL. Brentuximab vedotin will be administered as 1.8 mg/kg IV infusion on Day 1 of each 3-week cycle. PD-1 inhibitor tislelizumab will be administered as 200 mg on Day 1 of each 3-week cycle. Patients will receive maximum of 8 cycles if they do not meet the criteria for removal from the study. Patients will be assessed for overall response using the Revised Response Criteria for Malignant Lymphoma (Lugano 2014). Dedicated computed tomography (CT) scans (neck, chest, abdomen, and pelvis) will be performed at Baseline and at Cycles 2, 4 and 8, and positron emission tomography (PET) scans will be performed at Baseline and at Cycles 4 and 8. No additional PET scanning is required beyond Cycle 8 unless clinically indicated (for example, suspected of disease progression). The disease symptoms will be assessed at Baseline and on Day 1 of each cycle. Patients may continue study treatment until the sooner of disease progression, unacceptable toxicity, or completion of 8 cycles. Patients who discontinue study treatment for any reason other than withdrawal of consent will have safety follow-up assessments through 30 days after the last dose of 、study drug (end of treatment \[EOT\]). Patients who discontinue study treatment with stable disease (SD), responses and progression disease (PD) will be followed for 1-year PFS rate and 1-year OS rate. The CT scan, PET-CT and laboratory examination will be followed based on clinical practice. The study will be closed when all patients enrolled have completed the required follow-up.Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0 Laboratory values, vital signs, and electrocardiograms (ECGs) will be obtained to evaluate the safety and tolerability of study treatment.

Conditions

• NK/T Cell Lymphoma Nos

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin in Combination with Tislelizumab	Brentuximab vedotin will be administered after diluted with 100 ml normal saline as an IV infusion over approximately 30 minutes on Day 1 of each 21-day cycle at a dose of 1.8 mg/kg. Tislelizumab will be administered after diluted with 100 ml normal saline as an IV infusion over approximately 30 minutes on Day 1 of each 21-day cycle at a fixed dose of 200 mg. The rationale of fixed dose of Tislelizumab is according to the drug description, which is based on previous I/II phase clinical trial results of Tislelizumab. The time interval between administration of tislelizumab and brentuximab vedotin should be not less than 2 hours, and thereafter, the dosing cycle of tislelizumab is synchronized with that of brentuximab vedotin.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-06-01
• Completion: 2024-12-31
• First posted: 2022-04-07
• Last updated: 2022-04-07

Regulatory

• FDA-regulated drug study