NCT05335018

GPL in Patients with Relapsed/refractory Diffuse Large B Cell Lymphoma

Phase II Study of Glofitamab, Poseltinib and Lenalidomide in Patients with Relapsed/refractory Diffuse Large B Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Prospective, open-ended, single-arm, multicenter Phase II clinical trial. To evaluate the efficacy of Glofitamab, Poseltinib, and Lenalidomide combination therapy in patients with relapsed/refractory diffuse large B-cell lymphoma.

Detailed description

For outpatients or inpatients who meet the criteria for subject selection, the study is conducted with patients who have given a sufficient explanation of the study and who voluntarily consented to participate in the study. Patients enrolled in the study receive a combination therapy of glofitamab, poseltinib, and lenalidomide according to the criteria specified in the protocol. This therapy is defined as one cycle of 3 weeks, and a total of 12 cycles is planned. glofitamab is administered in steps. 2.5 mg on the 8th day of Cycle 1, 10 mg on the 15th day, 30 mg on the 1st day of Cycle 2, and then 30 mg intravenously on the 1st day of each cycle. poseltinib is administered orally at 40 mg BID daily from Day 1 to Day 21 of each cycle, and lenalidomide is administered orally at 30 mg QD daily from Day 1 to Day 14 of each cycle. Maintenance therapy is offered with poseltinib and lenalidomide only for patients with a partial response (PR) or complete response (CR). In addition, this study includes a salvage protocol for patients with CNS (central nerve system) lesions during patient recruitment. These patients are excluded from treatment with glofitamab because of the potential risk of CNS toxicity and will receive only poseltinib plus lenalidomide. The first 3+3 patients will proceed to a safety cohort, with dose adjustments for lenalidomide and poseltinib. These 6 persons were not included in the cohort evaluating the outcome of the study.

Conditions

• Relapsed/refractory Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Glofitamab, Poseltinib, Lenalidomide	Glofitamab: Increase from 2.5mg for 8days in 1 cycle to 10mg for 15days. 2cycles 1day 30mg, 30 mg on the 1st day of every week thereafter. Poseltinib: 40mg/day bid orally, administered daily from the 1st to the 21st of every week. Lenalidomide: 20mg/day bid orally, administered daily from the 1st to the 14st of every week.

Timeline

• Start date: 2022-05-30
• Primary completion: 2025-11-30
• Completion: 2026-11-30
• First posted: 2022-04-19
• Last updated: 2024-12-16

Locations

1 site across 1 country: South Korea