NCT03060850

A Phase I Study of AC0010 in Patients With CLL/ SLL, MCL, DLBCL and Other NHL

A Phase I Study of AC0010 in Patients With Relapsed or Refractory CLL/SLL, MCL, DLBCL and Other Non-Hodgkin B-Cell Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Hangzhou ACEA Pharmaceutical Research Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, dose escalation, phase I study to determine the recommended Phase 2 dose (PR2D) by assessing the DLT, safety and efficacy of AC0010 in patients with B-cell lymphoma.

Detailed description

This is an open label, dose escalation, phase I study to determine the PR2D by assessing the DLT, safety and efficacy of AC0010 in patients with B-cell lymphoma. This study includes two parts. During Part 1 Dose Escalation, the "3+3" design will be applied. Dose escalation will begin at dose level 1 = 400 mg. This dose escalation will be followed by an exploratory expansion phase in 3 or 4 groups of 15\~41 patients each (CLL group, MCL group, non-germinal center B cell-like DLBCL group, and/or FL/WM(macroglobulinemia) group). The study will further evaluate the safety and efficacy of AC0010 in these patients in each group

Conditions

• B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	AC0010MA	Participants in the dose escalation cohorts will be treated with AC0010MA every 28 days

Timeline

• Start date: 2017-03-17
• Primary completion: 2019-12-14
• Completion: 2020-12-14
• First posted: 2017-02-23
• Last updated: 2019-02-01

Locations

2 sites across 1 country: China