CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
SyB L-0501drug
Likely dose
SyB L-0501 100 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02042911
NCT02042911Phase 2Completed
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A Multicenter, Open-label Phase II Study of SyB L-0501 in Patients With Chronic Lymphocytic Lymphoma

SymBio Pharmaceuticals·interventional·Posted Jan 23, 2014·Updated Feb 1, 2017

In Brief

A Phase 2 clinical trial evaluating SyB L-0501 for Chronic Lymphocytic Leukemia. Completed, enrolled 10 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2014
Enrollment StartJan 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.4 years ago

Interventions

SyB L-0501drug

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.