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

NCT07749365 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-08-06

No results posted yet for this study

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.

Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma
  • PCNSL (Primary CNS Lymphoma)

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-25
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07749365 on ClinicalTrials.gov