GPL in Patients with Relapsed/refractory Diffuse Large B Cell Lymphoma
- Conditions
- Relapsed/refractory Diffuse Large B Cell Lymphoma
- Interventions
- Registration Number
- NCT05335018
- Lead Sponsor
- Seoul National University Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Glofitamab, Poseltinib, Lenalidomide total 2years. 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.
- Primary Outcome Measures
Name Time Method Efficacy evaluation of Gofitamab, Poseltinib, and Lenalidomide using endpoints At the end of Cycle 2 (each cycle is 28 days) Overall Response Rate according to Lugano criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of