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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhengzhou University

About this trial

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 criteria

Qualifiers

Understand and voluntarily sign the informed consent form.

Age 18-75 years (inclusive, including 18 and 75 years) at screening; no restriction on gender.

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)]).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Glofitamab treatment

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators