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RECRUITING
NCT07749365
PHASE2

Hypofractionated Radiotherapy Plus GM-CSF, Pomalidomide and Glofitamab for Newly Diagnosed PCNS-DLBCL

Sponsor: The First Affiliated Hospital of Xiamen University

View on ClinicalTrials.gov

Summary

This prospective study was conducted to evaluate the efficacy and safety of hypofractionated radiotherapy combined with granulocyte-macrophage colony-stimulating factor, pomalidomide and glofitamab in patients with newly diagnosed primary central nervous system diffuse large B-cell lymphoma.

Official title: A Prospective Phase II Clinical Study to Evaluate the Efficacy and Safety of Hypofractionated Radiotherapy Combined With Granulocyte-Macrophage Colony-Stimulating Factor, Pomalidomide and Glofitamab in Patients With Newly Diagnosed Primary Central Nervous System Diffuse Large B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2026-07-25

Completion Date

2029-12-31

Last Updated

2026-08-06

Healthy Volunteers

No

Interventions

DRUG

hypofractionated radiotherapy plus GM-CSF, pomalidomide and glofitamab

Treatment Regimen (Brief Version) * Hypofractionated radiotherapy: 5 Gy/day for 3 days, continued until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-cancer therapy, or other protocol-defined termination. * GM-CSF: 400 μg subcutaneously once daily for 3 days after radiotherapy and the first 3 days of each subsequent cycle. * Pomalidomide: 25 mg orally once daily for 14 days after radiotherapy, followed by days 1-14 of each 21-day cycle (cycles 2-6), with dose adjustment based on renal function and blood counts. * Glofitamab (bispecific antibody): Rituximab on day 1, glofitamab step-up dosing on day 8, followed by 30 mg every 21 days for 6 cycles. * Treatment duration: Until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-cancer therapy, or other protocol-defined discontinuation.

Locations (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China