NCT05950997

A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL

A Single Arm Study of Acalabrutinib Combined With Obinutuzumab in Chinese Patients With Treatment-Naive Chronic Lymphocytic Leukemia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, prospective study to assess the efficacy and safety of acalabrutinib combined with obinutuzumab in subjects with previously untreated chronic lymphocytic leukemia.

Detailed description

Subject participation will include a Screening Phase, a Treatment Phase, a Follow-up Phase.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Acalabrutinib	100 mg capsules administered by mouth once daily (28-day cycles)
DRUG	Obinutuzumab	100 mg administered intravenously on Day 1 and 900 mg administered intravenously on Day 2, 1000 mg administered intravenously on Day 8 and 15 of cycle 2 and 1000 mg on Day 1 of subsequent cycles for a total of 6 cycles (28-day cycles)

Timeline

• Start date: 2024-04-16
• Primary completion: 2026-05-31
• Completion: 2026-09-30
• First posted: 2023-07-18
• Last updated: 2024-05-09

Locations

1 site across 1 country: China