Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT07240194
Brief Summary:
This is a Phase II, open-label, single-arm, multicenter study designed to evaluate the safety and efficacy of a novel combination therapy-Glofitamab, a PD-1 inhibitor, and Lenalidomide (Glofit-PD-1-Len)-in patients with TP53-aberrant relapsed or refractory large B-cell lymphoma (R/R LBCL). The study will enroll 24 participants and utilize a Simon two-stage design to assess the best complete response rate (BCR), defined as achieving complete remission (CR) per 2014 Lugano criteria during the treatment period. Secondary endpoints include overall response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), and MRD negativity rate at the end of treatment. Safety and tolerability will also be evaluated. This study addresses a critical unmet need for patients with TP53-mutant R/R LBCL, who typically have a poor prognosis under current treatment options.
Detailed Description:
This is a Phase II, open-label, single-arm, multicenter study designed to evaluate the safety and efficacy of the Glofitamab-PD-1 inhibitor-Lenalidomide combination therapy (Glofit-PD-1-Len) in patients with TP53-aberrant relapsed or refractory large B-cell lymphoma (R/R LBCL). The study aims to investigate whether this novel therapeutic combination can effectively address the high unmet medical need in this patient population, characterized by poor prognosis and resistance to standard treatments.
The study employs a Simon two-stage design, enrolling a total of 24 participants. In Stage I, an initial cohort of 9 patients will be treated and evaluated. If fewer than 2 patients achieve complete response (CR) per 2014 Lugano criteria (as verified by FDG-PET imaging), the study will be terminated early. If the threshold is met, an additional 15 patients will be recruited in Stage II for further evaluation, bringing the total to 24 patients. The primary endpoint is the best complete response rate (BCR) achieved during the treatment cycle. Secondary endpoints include overall response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), duration of complete remission (DoCR), transplantation rate, and minimal residual disease (MRD)-negative rate at the end of treatment.
The treatment process consists of an induction stage following a screening period of up to 28 days. On Day 1 of the first treatment cycle, patients will receive pretreatment with Obinutuzumab, followed by Glofitamab with stepwise dose escalation, combined with the PD-1 inhibitor and Lenalidomide. Efficacy assessments will occur at predefined time points using Lugano response criteria. The safety of the Glofit-PD-1-Len regimen will be closely monitored, and adverse events will be recorded and graded per CTCAE version 5.0.
Patients will be excluded if they meet criteria such as prior organ transplant, recent exposure to other investigational treatments, or significant comorbid conditions, including active infections and uncontrolled autoimmune diseases. Concomitant therapies, such as corticosteroids (except for specific indications), experimental therapies, and live vaccines, are prohibited. Prophylactic measures for tumor lysis syndrome (TLS), nausea, vomiting, and diarrhea, as well as granulocyte colony-stimulating factor (G-CSF) support, will be implemented as per institutional guidelines.
The risk-benefit profile of this combination is supported by prior studies demonstrating the efficacy and acceptable safety of Glofitamab in combination therapies for LBCL. Given the significant treatment gap for TP53-aberrant R/R LBCL patients, this research seeks to advance outcomes through an innovative therapeutic approach.
Study:
NCT07240194
Study Brief:
Protocol Section:
NCT07240194