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

Conditions

• Relapsed/refractory Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Glofitamab, Poseltinib, Lenalidomide — DRUG
  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.

Study Details

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.

Key Dates

Start date

May 30, 2022

Status verified

Dec 2024

Primary completion

Nov 30, 2025

Completion

Nov 30, 2026

Study Design

Enrollment

76 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
  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 Measure

Efficacy evaluation of Gofitamab, Poseltinib, and Lenalidomide using endpoints [ Time Frame: At the end of Cycle 2 (each cycle is 28 days) ]