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.
Written informed consent must be obtained before any study-related procedures.
Age ≥18 years, regardless of sex, with an expected survival time >3 months.
Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
Newly diagnosed patients with primary central nervous system diffuse large B-cell lymphoma (PCNSL).
Loss of CD20 expression in B-cell non-Hodgkin lymphoma.
HBV DNA >2,000 IU/mL or >10⁴ copies/mL without willingness to receive regular antiviral therapy;
HCV RNA >10³ copies/mL;
Concurrent positivity for HBsAg and anti-HCV antibody.
Single group
hypofractionated radiotherapy plus GM-CSF, pomalidomide and glofitamab
DrugTreatment 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.
CR (Complete Response Rate)
The primary efficacy endpoint is the complete response (CR) rate, defined as the proportion of patients achieving complete response according to the Lugano response criteria.
ORR (Objective Response Rate)
Secondary efficacy endpoints include objective response rate (ORR), duration of response (DoR), and safety profile. ORR is defined as the proportion of patients achieving complete response or partial response according to the Lugano response criteria.
Duration of Response (DoR)
Duration of response is defined as the time from the first documented response (complete response or partial response) to disease progression, death, or the last disease assessment.
Click on the lead sponsor to view all of their trials.
