BridgeMD
New treatment option for Diffuse Large B-cell Lymphoma
Official title Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL
ClinicalTrials.gov ID: NCT06651853
What this study is testing
What is Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and Glofitamab?
Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and Glofitamab is an investigational medicine, being studied as a potential treatment for diffuse large b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 but are transplant-ineligible after 1 line of...
You likely can't join if
- 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...
- Participants have received anti-hematologic malignancy treatment within 2 weeks before the start of treatment or within 5 half-lives of the drug...
- 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...
- Uncontrolled hypertension, with systolic blood pressure \>150mmHg or diastolic blood pressure \>90mmHg after optimal medical treatment, history of...
See the full eligibility criteria
Who can 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 but are transplant-ineligible after 1 line of systemic therapy, or relapsed disease after 2+ lines of therapy)...
- Participants must not have received bispecific antibody therapy in the past.
- 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...
- 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...
- 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...
What rules you out
- 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)...
- 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...
- Uncontrolled hypertension, with systolic blood pressure \>150mmHg or diastolic blood pressure \>90mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.