NCT03992339

A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

An Open-label and Single Arm Study of ATG-010 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Antengene Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single arm, and registered study of ATG-010 in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma.

Detailed description

This is an open-label, single arm, and registered study. About 60 patients with relapsed/refractory DLBCL plan to be enrolled in about 10 study sites of the study. It is planned that at least 50% (\~30 patients) will have the GCB subtype of DLBCL. Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle. Patients should remain on the study treatment of ATG-010, until either PD or occurrence of unacceptable toxicity.

Conditions

• Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle	Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.

Timeline

• Start date: 2020-04-09
• Primary completion: 2023-05-31
• Completion: 2023-12-01
• First posted: 2019-06-20
• Last updated: 2025-02-07
• Results posted: 2025-02-07

Locations

18 sites across 1 country: China