Hypofractionation Radiotherapy + Glofitamab in Relapsed/Refractory DLBCL with High Tumor Burden

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial evaluates the safety and efficacy of combining hypofractionation radiotherapy with glofitamab in adults with relapsed/refractory DLBCL and high tumor burden. Eligible participants have previously received systemic therapy and meet specific tumor-burden criteria. The approach is planned for patients with CD20-positive DLBCL, aiming to improve complete response rates by modifying the tumor environment prior to or during antibody-based therapy. Outcomes will include response rates, survival measures, and safety signals related to the combination. The study is led by a single investigator team at a major Chinese center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent.
* Aged 18-75 years at the time of signing the informed consent, willing to follow and able to complete all study procedures.
* Expected survival ≥ 12 weeks.
* ECOG performance status score of 0-2 points ;
* Patients with CD20-positive DLBCL confirmed by pathological histology; (unspecified DLBCL, HGBCL, PMBCL, FL-transformed DLBCL).
* R/R DLBCL who have received at least one line of systemic treatment (including at least 2 cycles of rituximab-containing immunochemotherapy).
* Baseline high tumor burden, defined as tumor diameter \> 6 cm and/or TMTV \> 128.7 mL .
* HIV test results were negative at screening, except for the following: HIV-positive patients who have been receiving stable antiretroviral therapy and CD4 count ≥ 200/µL before enrollment Patients with undetectable viral load can be enrolled.
* Women of childbearing age with negative urine or blood pregnancy test within 7 days before enrollment need to agree to take effective contraceptive measures during treatment and follow-up.

Exclusion Criteria:

* Individuals who have drug allergies or metabolic disorders to the drugs in this protocol.
* Previous recipients of allogeneic organ transplants.
* Individuals who received systemic immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) of the drug.
* Anti-cancer drug treatment within 28 days before the start of treatment
* Prior radiotherapy in the mediastinum/pericardium area; radiation therapy for non-target lesion sites is allowed.
* History of severe or extensive cardiovascular disease.
* Recent major surgery (within 4 weeks before the start of Cycle 1), excluding diagnostic surgeries.
* Currently suffering from active CNS lymphoma.
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
* Current or previous history of concurrent Waldenström's macroglobulinemia.
* Known active infection at the time of enrollment in the study.
* Immune-related adverse events that appeared during prior immunotherapy: ≥Grade 3 adverse events, except for Grade 3 endocrine diseases controlled by alternative therapies. Grade 1 or 2 adverse events that did not return to baseline levels after stopping treatment.
* History of autoimmune diseases (long-standing or well-controlled autoimmune diseases, hypothyroidism, immune thrombocytopenic purpura, and well-controlled Type I diabetes are excluded).
* Abnormal coagulation function: INR or PT \>1.5× upper limit of normal (ULN), PTT or aPTT \>1.5× ULN.
* Suspected or latent tuberculosis (confirmed by positive IFNγ release test)
* Active hepatitis B virus (HBV) infection/positive HCV RNA test for hepatitis C virus (HCV)/HIV seropositive.
* Previously suffered from other invasive malignancies, excluding early-stage cervical cancer, basal cell carcinoma of the skin, and thyroid cancer .
* Pregnant or breastfeeding, or planning to become pregnant during the study period or within 18 months after pre-treatment with obinutuzumab or within 2 months after the last dose of glofitamab (whichever is longer).
* Other concurrent uncontrolled medical conditions that, in the investigator's opinion, would affect the patient's participation in the study.

Where it's running

• Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Liling Zhang
• Email: lily1228@sina.com
• Phone: 0086 27 83262660

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Glofit-GemOx Bridging to Liso-cel for Relapsed/Refractory Large B-Cell Lymphoma

  This trial tests whether a bridging therapy with Glofit-GemOx followed by lisocabtagene maraleucel helps people with relapsed or refractory large B-cell lymphoma.

  Recruiting Phase 2 Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT07711483

• Evaluating Glofitamab for Relapsed Mantle Cell Lymphoma

  This study is testing if a new treatment called glofitamab can work better than standard options for people with relapsed mantle cell lymphoma.

  Recruiting at 62 sites Phase 3 Hoffmann-La Roche · Berkeley, California and 82 other locations · NCT06084936

• Glofitamab and Polatuzumab with R-CHP for high-risk diffuse large B-cell lymphoma

  This will test whether adding the immunotherapies glofitamab and polatuzumab to standard R-CHP chemotherapy helps adults with previously untreated high-risk diffuse large B-cell lymphoma.

  Recruiting at 3 sites Phase 2 Dana-Farber Cancer Institute · Miami, Florida and 2 other locations · NCT05800366

• LB-208: a new oral treatment for adults with advanced solid tumors or lymphoma

  This early study tests whether LB-208, taken once daily by mouth, is safe for adults with advanced solid tumors or lymphoma who have exhausted standard treatments.

  Recruiting Phase 1 Leukos Biotech S.L. · Barcelona, Barcelona · NCT07914348

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

• CD19/CD22 CAR-T consolidation after second-line therapy for high-risk aggressive B-cell lymphoma

  This trial tests whether CD19/CD22 CAR-T cell therapy given after a second-line response can help people with high-risk aggressive B-cell lymphoma stay in remission.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing · NCT07779018

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.