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DLBCL - Diffuse Large B Cell LymphomaPhase 2NCT07749365

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

A Phase 2 study testing hypofractionated radiotherapy plus GM-CSF, pomalidomide and glofitamab in people with DLBCL - Diffuse Large B Cell Lymphoma and PCNSL (Primary CNS Lymphoma), run by The First Affiliated Hospital of Xiamen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
hypofractionated radiotherapy plus GM-CSF, pomalidomide and glofitamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
25 Jul 2026to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • 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.
  • HIV infection (positive HIV-1/2 antibody) or known syphilis infection.
  • Presence of unhealed wounds, fractures, gastric or duodenal ulcers, persistent positive fecal occult blood test, ulcerative colitis, or other conditions associated with risk of gastrointestinal bleeding or perforation as determined by the investigator.
  • Active or uncontrolled severe infection, including severe infection requiring hospitalization due to infection, bacteremia, or severe pneumonia within 4 weeks before the first dose.
  • Major surgery or significant traumatic injury within 4 weeks before the first dose.
  • Use of traditional Chinese medicine with antitumor indications within 2 weeks before the first dose.
  • Known hypersensitivity to any component of bispecific antibodies or GM-CSF preparations.
  • Receipt of treatment in another clinical trial within 4 weeks before the first dose.
  • Pregnant or breastfeeding women.
  • Active autoimmune disease or history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, and nephritis. Patients requiring medical intervention with bronchodilators for asthma are excluded. The following conditions are permitted: vitiligo, psoriasis, alopecia, or controlled type I diabetes not requiring systemic treatment, and hypothyroidism controlled with hormone replacement therapy.
  • Any other acute or chronic disease, psychiatric condition, or abnormal laboratory finding that may:
  • Increase the risk associated with study participation or administration of study treatment;
  • Interfere with interpretation of study results;
  • Render the patient unsuitable for participation according to the investigator's judgment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhijian Lin, Dr contact

15960283462 ext. +86

zjuan_lin@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Zhijuan Lin, Dr, 15960283462 ext. +86, zjuan_lin@126.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
hypofractionated radiotherapy plus GM-CSF, pomalidomide and glofitamab
Medical subject headings
Dendritic Cell Sarcoma, Interdigitating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hypofractionated radiotherapy plus GM-CSF, pomalidomide and glofitamabDrug

    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.
Study groups in NCT07749365
Study groupRoleWhat they receive
hypofractionated radiotherapy combined with granulocyte-macrophage colony-stimulatingExperimentalAfter 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
Receives: Drug: hypofractionated radiotherapy plus GM-CSF, pomalidomide and glofitamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 12 months

Secondary outcomes (2)

  1. 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.

    Measured: Up to 12 months

  2. 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.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start25 Jul 2026 (estimated)
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07749365
Sponsor's protocol ID
XMDYYYXYK-0722
Status last verified
Aug 2026
First submitted
22 Jul 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hypofractionated radiotherapy plus GM-CSF, pomalidomide and glofitamab in people with DLBCL - Diffuse Large B Cell Lymphoma and PCNSL (Primary CNS Lymphoma), run by The First Affiliated Hospital of Xiamen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhijian Lin, Dr (15960283462 ext. +86, zjuan_lin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CR (Complete Response Rate) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07749365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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