Loading clinical trials...

Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE4

Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma

Prospective Clinical Study of Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma

NCT06956092•Zhengzhou University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if Glofitamab works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of Glofitamab treatment. The main questions it aims to answer are: * Does Glofitamab treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment? * What medical problems do participants have when receiving Glofitamab treatment? In this investigator-initiated, single-arm clinical trial, participants will: * Receive Glofitamab treatment as per the instructions in the package insert. * Visit the clinic as instructed for checkups and tests.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Understand and voluntarily sign the informed consent form.
•2. Age 18-75 years (inclusive, including 18 and 75 years) at screening; no restriction on gender.
•3. Diagnosed with B-cell non-Hodgkin lymphoma according to the 2022 WHO Classification of Tumors of Hematopoietic and Lymphoid Tissues (5th edition). The following subtypes are included in this trial:
•1\) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), defined as high-risk disease meeting at least one of the following criteria: IPI score of 4-5 at initial diagnosis, TP53 negativity or overexpression (\>50%) or TP53 mutation identified by gene sequencing, MYC rearrangement, CD5(+), MYC and BCL2 co-expression.
•2\) Follicular lymphoma-transformed large B-cell lymphoma. 3) High-grade B-cell lymphoma (HGBL) with MYC and BCL2 rearrangement. 4) High-grade B-cell lymphoma, not otherwise specified (HGBL-NOS). 5) Intravascular large B-cell lymphoma. 6) Large tumor mass (≥7.5 cm). 4. Histopathologically and/or cytologically confirmed CD20-positive large B-cell lymphoma patients who have achieved CR, Cru, or VGPR after prior first-line treatment with rituximab-containing chemoimmunotherapy.
•5\. Expected survival ≥12 weeks. 6. Target lesion defined as a lymph node-based lesion with a long diameter ≥15 mm or an extranodal lesion \>10 mm (according to Lugano 2014 criteria); lesions previously treated with radiotherapy must show clear progression post-radiation to be considered measurable.
•8\. Adequate bone marrow reserve, defined as: neutrophil count ≥1.0×10\^9/L; lymphocyte count ≥0.2×10\^9/L; hemoglobin \>80 g/L; platelets \>80×10\^9/L.
•9\. Non-hematologic toxicities caused by prior treatments (excluding disease-related conditions) must have resolved to ≤Grade 1 prior to enrollment (except alopecia and chemotherapy-induced Grade ≥2 neurotoxicity).
•10\. Appropriate organ function, meeting the following criteria (excluding abnormalities caused by tumor infiltration):
•Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≤3 times ULN; total serum bilirubin ≤2 times ULN, unless Gilbert syndrome is present. Patients with Gilbert syndrome can be included if total bilirubin ≤3 times ULN and direct bilirubin ≤1.5 times ULN.
+24 more criteria

Exclusion Criteria

•1. History of severe allergy or hypersensitivity reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).
•2. Received autologous hematopoietic stem cell transplantation (ASCT) within 100 days prior to the first dose of Glofitamab; received chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to the first dose of Glofitamab.
•3. Previously underwent allogeneic stem cell transplantation or allogeneic CAR-T therapy.
•4. History of solid organ transplantation.
•5. History of acute or chronic active hepatitis B or hepatitis C infection. Patients with a history of hepatitis must demonstrate viral clearance based on standard serological and genetic testing (i.e., hepatitis B surface antibody positive, other markers negative, and HBV DNA PCR negative) to be eligible; other cases require approval from the medical monitor.
•6. Infection with human immunodeficiency virus (HIV).
•7. Known or suspected chronic active Epstein-Barr virus (CAEBV) infection.
•8. Presence of uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding nail bed fungal infections) at screening or occurrence of any serious infection within 4 weeks prior to the first infusion of Glofitamab (as judged by the investigator).
•9. Current or history of central nervous system (CNS) disorders such as seizures, ischemic/hemorrhagic cerebrovascular events, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric disorders, or autoimmune diseases involving the CNS.
•10. History of autoimmune diseases, including but not limited to: myasthenia gravis, polymyositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-associated vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, glomerulonephritis, or active autoimmune cytopenias (autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\]).
+3 more criteria

Locations (1)

The First Affiliated Hospital of Zhengzhou University, Department of Oncology

Zhengzhou, Henan, China

Key Dates

Start Date

May 30, 2025

Primary Completion Date

June 1, 2028

Completion Date

December 1, 2028

Last Updated

May 2, 2025

Enrollment

ESTIMATED participants

Conditions

B Cell Lymphoma (BCL)

Interventions

Glofitamab treatment

BIOLOGICAL

Contacts

Zhang, PhD

CONTACT

86-0371-66279567 fcczhangxd@zzu.edu.cn

Multi-CAR-T Cells Targeting B Cell Lymphomas

NCT04429438

B Cell Lymphoma (BCL)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions