CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
SyB L-0501 +1 moredrug
Likely dose
SyB L-0501 120 mgfrom 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/NCT01118845
NCT01118845Phase 2Completed
CompareCT.gov

A Multinational, Multicenter, Open-Label Phase II Study of SyB L-0501 in Combination With Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

SymBio Pharmaceuticals·interventional·Posted May 7, 2010·Updated Jul 4, 2013

In Brief

A Phase 2 clinical trial evaluating SyB L-0501 and Rituximab for Non-Hodgkin's Lymphoma and 4 related conditions. Completed, enrolled 63 participants across 25 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma, Lymphoma, Large Cell, Diffuse, Mantle Cell Lymphoma, Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse
CountriesJapan, South Korea
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2010
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.2 years ago

Interventions

SyB L-0501drug

The administration of SyB L-0501 at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. SyB L-0501 60 mg/m\^2, 90 mg/m\^2 or 120 mg/m\^2/day on Day 2 and Day 3 will be followed by 18 days of observation.

Rituximabdrug

The administration of rituximab at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.