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

NCT06956092 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-IIT-0013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

B Cell Lymphoma (BCL)

Outcome Measures

Primary Outcomes (1)

• two year PFS

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Study Arms (1)

Experimental: Glofitamab treatment

EXPERIMENTAL

Biological: Glofitamab treatment

Interventions

Glofitamab treatment BIOLOGICAL

eceive Glofitamab treatment as per the instructions in the package insert.

Experimental: Glofitamab treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign the informed consent form.
• Age 18-75 years (inclusive, including 18 and 75 years) at screening; no restriction on gender.
• 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:
• \) 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.
• \) 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.
• \. 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.
• \. 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.
• \. 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).
• \. 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.
• Serum creatinine ≤1.5 times ULN or creatinine clearance ≥60 mL/min (using Cockcroft-Gault formula: Male CrCl = \[(140-age) × weight (kg)\] / \[0.818 × creatinine (μmol/L)\]; Female CrCl = \[(140-age) × weight (kg) × 0.85\] / \[0.818 × creatinine (μmol/L)\]).
• Minimum pulmonary reserve: ≤Grade 1 dyspnea (CTCAE v5.0) and oxygen saturation ≥92% under non-oxygenated conditions.
• Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; no clinically significant ECG abnormalities; no clinically significant pericardial effusion or pleural effusion.
• International normalized ratio (INR) ≤1.5 times ULN and activated partial thromboplastin time (APTT) ≤1.5 times ULN.
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 12. No central nervous system lymphoma determined by cranial MRI. 13. Women of childbearing potential must have a negative blood/urine pregnancy test within 7 days prior to infusion. All male and female patients capable of reproduction must agree to use effective contraception throughout the study and for at least 2 years after study treatment administration. A patient is deemed capable of reproduction based on their biological ability to conceive and normal sexual activity, as judged by the investigator. Women are deemed incapable of reproduction if they meet at least one of the following criteria: medically-confirmed ovarian failure, hysterectomy, bilateral oophorectomy, or post-menopausal status (defined as cessation of menstruation for at least 12 consecutive months).

You may not qualify if:

• History of severe allergy or hypersensitivity reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).
• 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.
• Previously underwent allogeneic stem cell transplantation or allogeneic CAR-T therapy.
• History of solid organ transplantation.
• 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.
• Infection with human immunodeficiency virus (HIV).
• Known or suspected chronic active Epstein-Barr virus (CAEBV) infection.
• 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).
• 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.
• 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 \[ITP\]).
• Patients with long-standing or well-controlled autoimmune diseases may be eligible after discussion and confirmation with the investigator.
• Patients with autoimmune thyroid dysfunction receiving stable doses of thyroid replacement hormone may be eligible.
• Patients with well-controlled Type 1 diabetes (defined as fasting HbA1c \<8% at screening and no ketoacidosis) are eligible.
• Patients with skin-limited conditions such as eczema, psoriasis, chronic lichen simplex, or vitiligo may be eligible if the following criteria are met:
• Rash involves \<10% of body surface area.

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University, Department of Oncology

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Zhang, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)