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

NCT07749365 | Recruiting Phase 2

• 1 other identifier: XMDYYYXYK-0722
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months

Secondary Outcomes (2)

• ORR (Objective Response Rate)

  Up to 12 months

• Duration of Response (DoR)

  Up to 12 months

Study Arms (1)

hypofractionated radiotherapy combined with granulocyte-macrophage colony-stimulating

EXPERIMENTAL

After signing the informed consent, patients may receive pretreatment with dexamethasone (10 mg/day, maximum dose 30 mg) and/or pomalidomide 4 mg/day for up to 7 days. In Cycle 1, patients receive hypofractionated radiotherapy at 5 Gy per day for 3 consecutive days. One to two cycles of radiotherapy will be administered for a single target lesion, with the radiotherapy regimen determined by the investigator. GM-CSF at 400 μg once daily is administered for 3 consecutive days starting on Day 1 after radiotherapy completion. Pomalidomide 4 mg once daily is given for 14 consecutive days starting on Day 1 after radiotherapy completion. If pomalidomide is used during pretreatment, the total duration of pomalidomide (pretreatment plus post-radiotherapy administration) shall not exceed 14 days. Dose escalation of glofitamab commences on Day 7 after radiotherapy completion. Cycles 2 to 6 are administered on a 21-day cycle schedule. GM-CSF 400 μg once daily is given for 3 consecutive days start

Drug: hypofractionated radiotherapy plus GM-CSF, pomalidomide and glofitamab

Interventions

hypofractionated radiotherapy plus GM-CSF, pomalidomide and glofitamab DRUG

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.

hypofractionated radiotherapy combined with granulocyte-macrophage colony-stimulating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• No previous treatment with bispecific antibodies.
• B-cell non-Hodgkin lymphoma with at least one measurable lesion according to RECIST 1.1 criteria, or detectable abnormal monoclonal B cells by cerebrospinal fluid (CSF) flow cytometry.
• Adequate organ function meeting the following laboratory criteria:
• Total bilirubin ≤1.5 × upper limit of normal (ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN;
• Serum creatinine ≤1.5 × ULN and creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula);
• Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN.
• Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose of study treatment (Cycle 1 Day 1). If urine pregnancy testing cannot confirm a negative result, a serum pregnancy test is required. Women of non-childbearing potential are defined as those who are postmenopausal for ≥1 year or have undergone surgical sterilization or hysterectomy.
• All participants with reproductive potential (male or female) must use highly effective contraception with a failure rate \<1% per year during treatment and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy).

You may not qualify if:

• Loss of CD20 expression in B-cell non-Hodgkin lymphoma.
• Active acute or chronic hepatitis B or hepatitis C infection, including:
• 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.
• Receipt of anti-hematologic malignancy therapy within 2 weeks or within 5 pharmacokinetic half-lives before treatment initiation, whichever is longer.
• Inadequate bone marrow reserve, defined as platelet count \<30 ×10⁹/L or absolute neutrophil count \<1.0 ×10⁹/L.
• Clinically significant pulmonary diseases, including:
• Chronic obstructive pulmonary disease (COPD) with FEV1 \<50% of predicted value;
• Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any severity.
• Uncontrolled hypertension despite optimal medical management (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg), history of hypertensive crisis, or hypertensive encephalopathy.
• Symptomatic congestive heart failure (NYHA class II-IV), symptomatic or poorly controlled arrhythmias, congenital long QT syndrome, or corrected QT interval (QTc) \>500 ms (Fridericia correction).
• Receipt of hypofractionated radiotherapy within 4 weeks before the first treatment. Patients receiving radiotherapy \>4 weeks before enrollment must have no ongoing radiation-related toxicities, no requirement for corticosteroids, and no evidence of radiation pneumonitis, hepatitis, enteritis, or other radiation-related complications.
• Difficulty swallowing oral medications.
• History or presence of pulmonary fibrosis, interstitial lung disease, pneumoconiosis, drug-induced pneumonitis, or severe pulmonary dysfunction.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; pomalidomide; glofitamab

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Zhijian Lin, Dr

CONTACT

15960283462; zjuan_lin@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 6, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-08

Locations

CN (1)