Diffuse Large B-cell LymphomaPhase 2NCT06651853
Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL
A Phase 2 study testing Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and Glofitamab in people with Diffuse Large B-cell Lymphoma and Relapsed and Refractory, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To prospectively evaluate the efficacy and safety of large fraction radiation therapy combined with granulocyte-macrophage colony-stimulating factor, lenalidomide, and glofitamab monoclonal antibody in the treatment of refractory relapsed diffuse large B-cell lymphoma patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma, Relapsed and Refractory
- What is being tested?
- Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and Glofitamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2024to 30 Jul 2028
- 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 trial-related procedures are implemented.
- Participants must be aged 18 or older, of any gender, with an expected survival period of more than 3 months.
- ECOG PS score must be between 0-3.
- Participants must have histopathologically confirmed diffuse large B-cell lymphoma.
- Patients who have failed first-line standard treatment (patients with relapsed disease < 12 months or primary refractory disease, or relapsed disease > 12 months but are transplant-ineligible after 1 line of systemic therapy, or relapsed disease after 2+ lines of therapy). Participants with central nervous system metastasis can be included.
- Participants must not have received bispecific antibody therapy in the past.
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- B-cell non-Hodgkin's lymphoma must have at least one measurable lesion according to RECIST1.1 criteria.
- Participants must have sufficient organ function, meeting the following:
- laboratory criteria: (1) Total bilirubin ≤1.5× upper limit of normal (ULN); (2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; (3) Blood creatinine ≤1.5× ULN and creatinine clearance rate (calculated using the Cockcroft-Gault formula) ≥60 ml/min; (4) Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN.
- For women of childbearing potential, a urine or serum pregnancy test must be conducted within 3 days before the first administration of the study drug (Day 1 of Cycle 1) and the results must be negative. If the results of the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing women are defined as those who have been menopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy.
- If there is a risk of pregnancy, all participants (both male and female) must use contraception with an annual failure rate of less than 1% throughout the treatment period and for 120 days after the last administration of the study drug (or 180 days after the last chemotherapy administration).
Who cannot join
- B-cell non-Hodgkin's lymphoma with loss of CD20 expression.
- Acute or chronic active Hepatitis B or C infection, Hepatitis B virus (HBV) DNA>2000IU/ml or 104 copies/ml; Hepatitis C virus (HCV) RNA>103 copies/ml; simultaneous positivity for Hepatitis B surface antigen (HbsAg) and anti-HCV antibody.
- Participants have received anti-hematologic malignancy treatment within 2 weeks before the start of treatment or within 5 half-lives of the drug, whichever is longer.
- Bone marrow insufficiency defined by platelet count <30 x 109/L or absolute neutrophil count <1.0 x 109/L.
- Participants with clinically significant pulmonary disease, including (1) participants with chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of the predicted normal value. Note that participants suspected of having COPD need to undergo an FEV1 test, and if FEV1<50% of the predicted normal value, the participant must be excluded. (2) Participants with moderate or severe persistent asthma in the past 2 years, or currently have any category of uncontrolled asthma. (Note that participants currently with controlled intermittent asthma or controlled mild persistent asthma can participate in this study).
- Uncontrolled hypertension, with systolic blood pressure >150mmHg or diastolic blood pressure >90mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
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- Symptomatic congestive heart failure (New York Heart Association class II-IV). Symptomatic or poorly controlled arrhythmias. History of congenital long QT syndrome or a corrected QTc >500ms (calculated using the Fridericia method) at screening.
- Large fraction radiation therapy received within 4 weeks prior to the first treatment. For patients who received radiation therapy more than 4 weeks before the first treatment, all the following conditions must be met to be included: there are currently no radiation-related toxic reactions, no need to take glucocorticoids, excluding radiation pneumonia, radiation hepatitis, radiation enteritis, etc.
- Patients who have difficulty swallowing oral medications.
- Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, and other lung diseases.
- Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), known syphilis infection.
- Presence of unhealed wounds, fractures, gastric and duodenal ulcers, persistent fecal occult blood positivity, ulcerative colitis, etc., or other conditions that the investigator determines may cause gastrointestinal bleeding or perforation.
- Active or poorly controlled severe infection. Severe infection within 4 weeks before the first administration, including but not limited to hospitalization for complications of infection, sepsis, or severe pneumonia.
- Major surgical treatment or significant traumatic injury received within 4 weeks before the first administration.
- Traditional Chinese medicine with anti-tumor indications received within 2 weeks before the first administration.
- Known allergy to any component of bispecific antibodies or GM-CSF formulations.
- Treatment in another clinical trial within 4 weeks before the first administration.
- Pregnant or breastfeeding female patients.
- Presence of any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; participants who need bronchodilators for medical intervention for asthma cannot be included); but the following patients are allowed to participate: vitiligo, psoriasis, alopecia, well-controlled type I diabetes that does not require systemic treatment, and hypothyroidism with normal thyroid function through replacement therapy.
- Other acute or chronic diseases, mental illnesses, or abnormal laboratory test values that may lead to the following results: increase the risk associated with study participation or administration of the study drug, or interfere with the interpretation of study results, and according to the investigator's judgment, the patient is deemed ineligible to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Zhijuan Lin, Dr, 15960283462, zjuan_lin@126.com
About this study
Official title: The Efficacy and Safety of Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab Monoclonal Antibody in the Treatment of Refractory Relapsed Diffuse Large B-cell Lymphoma Patients
To prospectively evaluate the efficacy and safety of large fraction radiation therapy combined with granulocyte-macrophage colony-stimulating factor, lenalidomide, and glofitamab monoclonal antibody in the treatment of refractory relapsed diffuse large B-cell lymphoma patients
- Being tested
- Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and Glofitamab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and GlofitamabDrug
Large fraction radiotherapy is administered at 5Gy/day for 3 days, with one to two courses carried out on a single target lesion as determined by the investigator. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is administered at 400µg per day for 3 days starting on the first day after the end of radiotherapy. Lenalidomide is administered at 25mg per day for 14 days starting on the first day after the end of radiotherapy. Glofitamab is administered starting on the 7th day after the end of radiotherapy.
For cycles 2-6, each cycle is 21 days. GM-CSF is administered at 400µg per day for 3 days starting on the first day of each cycle. Glofitamab is administered at 30mg on the 4th day of each cycle. Lenalidomide is administered at 25mg per day for 14 days starting on the first day. Treatment consists of 6 cycles or until disease progression, death, intolerable toxicity, withdrawal of informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Large fraction radiation therapy plus GM-CSF, Lenalidomide, and Glofitamab Receives: Drug: Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and Glofitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR
Complete remission rate, according to Lugano 2014 criteria.
Measured: Up to 36 months
Secondary outcomes (1)
ORR
Overall remission rate, according to Lugano 2014 criteria.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start21 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 22 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijuan Lin, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651853
- Sponsor's protocol ID
- XMDYYYXYK-13
- Status last verified
- Jul 2025
- First submitted
- 19 Oct 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab Monoclonal Antibody in the Treatment of Refractory Relapsed Diffuse Large B-cell Lymphoma Patients
- ClinicalTrials.gov ID
- NCT06651853
- Acronym / sponsor ID
- XMDYYYXYK-13
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prospectively evaluate the efficacy and safety of large fraction radiation therapy combined with granulocyte-macrophage colony-stimulating factor, lenalidomide, and glofitamab monoclonal antibody in the treatment of refractory relapsed diffuse large B-cell lymphoma patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and GlofitamabLarge fraction radiation therapy plus GM-CSF, Lenalidomide, and Glofitamab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent must be obtained before any trial-related procedures are implemented.
- Participants must be aged 18 or older, of any gender, with an expected survival period of more than 3 months.
- ECOG PS score must be between 0-3.
- Participants must have histopathologically confirmed diffuse large B-cell lymphoma.
- Patients who have failed first-line standard treatment (patients with relapsed disease < 12 months or primary refractory disease, or relapsed disease > 12 months but are transplant-ineligible after 1 line of systemic therapy, or relapsed disease after 2+ lines of therapy). Participants with central nervous system metastasis can be included.
Key exclusion criteria (20 listed)
- B-cell non-Hodgkin's lymphoma with loss of CD20 expression.
- Acute or chronic active Hepatitis B or C infection, Hepatitis B virus (HBV) DNA>2000IU/ml or 104 copies/ml; Hepatitis C virus (HCV) RNA>103 copies/ml; simultaneous positivity for Hepatitis B surface antigen (HbsAg) and anti-HCV antibody.
- Participants have received anti-hematologic malignancy treatment within 2 weeks before the start of treatment or within 5 half-lives of the drug, whichever is longer.
- Bone marrow insufficiency defined by platelet count <30 x 109/L or absolute neutrophil count <1.0 x 109/L.
- Participants with clinically significant pulmonary disease, including (1) participants with chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of the predicted normal value. Note that participants suspected of having COPD need to undergo an FEV1 test, and if FEV1<50% of the predicted normal value, the participant must be excluded. (2) Participants with moderate or severe persistent asthma in the past 2 years, or currently have any category of uncontrolled asthma. (Note that participants currently with controlled intermittent asthma or controlled mild persistent asthma can participate in this study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and GlofitamabLarge fraction radiotherapy is administered at 5Gy/day for 3 days, with one to two courses carried out on a single target lesion as determined by the investigator. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is administered at 400µg per day for 3 days starting on the first day after the end of radiotherapy. Lenalidomide is administered at 25mg per day for 14 days starting on the first day after the end of radiotherapy. Glofitamab is administered starting on the 7th day after the end of radiotherapy. For cycles 2-6, each cycle is 21 days. GM-CSF is administered at 400µg per day for 3 days starting on the first day of each cycle. Glofitamab is administered at 30mg on the 4th day of each cycle. Lenalidomide is administered at 25mg per day for 14 days starting on the first day. Treatment consists of 6 cycles or until disease progression, death, intolerable toxicity, withdrawal of informed consent. | Drug | Treatment arm |
Primary outcome
CR
Time frame: Up to 36 months
Complete remission rate, according to Lugano 2014 criteria.
1 secondary outcome
ORR
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and Glofitamab in people with Diffuse Large B-cell Lymphoma and Relapsed and Refractory, 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 11 inclusion and 20 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 23 Jul 2025. 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 Zhijuan Lin, Dr (15960283462, 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 (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2025.