Status:
NOT_YET_RECRUITING
Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
Lead Sponsor:
Zhengzhou University
Conditions:
B Cell Lymphoma (BCL)
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 Glofitama...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 7\. Patients with occult or early-stage hepatitis B infection (defined as HBcAb positive and HBsAg negative) are eligible for inclusion if HBV DNA PCR testing is negative. These patients will undergo monthly HBV DNA PCR monitoring. Patients seropositive for HCV antibodies are eligible if HCV RNA PCR testing is negative.
- 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.
- 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.
- 11\. 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).
Exclusion
- \*\*
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06956092
Start Date
May 30 2025
End Date
December 1 2028
Last Update
May 2 2025
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University, Department of Oncology
Zhengzhou, Henan, China, 450052