NCT02042911

Efficacy and Safety Study of SyB L-0501 for Patients With Chronic Lymphocytic Leukemia

A Multicenter, Open-label Phase II Study of SyB L-0501 in Patients With Chronic Lymphocytic Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: SymBio Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate safety and efficacy of SyB L-0501 after 2-day intravenous infusion at a dose of 100 mg/m2/day to patients with chronic lymphocytic leukemia.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	SyB L-0501	SyB L-0501 is administered at 100 mg/m2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-01-23
• Last updated: 2017-02-01
• Results posted: 2016-03-29

Locations

6 sites across 1 country: Japan