CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
SyB L-0501 +1 moredrug
Likely dose
SyB L-0501 90 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/NCT01718691
NCT01718691Phase 2Completed
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Phase II Clinical Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B-cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma (Multicenter, Open-label).

SymBio Pharmaceuticals·interventional·Posted Oct 31, 2012·Updated Apr 27, 2016

In Brief

A Phase 2 clinical trial evaluating SyB L-0501 and rituximab for Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated. Completed, enrolled 70 participants across 14 sites.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma where hematopoietic stem cell transplantation is not indicated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow-grade B Cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2012
Enrollment StartNov 1, 2011
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 13.7 years ago

Interventions

SyB L-0501drug

A dose of 90 mg/m\^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.

rituximabdrug

A dose of 375 mg/m\^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.