NCT01982175

Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia

A Multi-center, Open, Prospective, Phase II Study of Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection in Patients With Relapse and Refractory B-cell Chronic Lymphocytic Leukemia

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai Zhangjiang Biotechnology Limited Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic leukemia.

Conditions

• B-cell Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Alemtuzumab	Escalation Phase: Initial Doses of Alemtuzumab 3mg/day by intravenous(IV) infusion until tolerated, then Alemtuzumab 10mg/day IV infusion until tolerated, then Alemtuzumab 30mg IV infusion until tolerated. Escalation to 30mg/day should be accomplished in 3\~7 days. Stable dose Phase: Once 30mg/day infusion of Alemtuzumab was tolerated, then continue 3 times per week. The total duration of Alemtuzumab therapy including escalation and stable dose phase is 12 weeks. More than 30mg daily or 90mg weekly dose is prohibited \--------------------------------------------------------------------------------

Timeline

• Start date: 2011-07-01
• Primary completion: 2021-02-01
• Completion: 2022-06-01
• First posted: 2013-11-13
• Last updated: 2022-06-21

Locations

1 site across 1 country: China