A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

March 31, 2010

Study Completion Date

May 31, 2010

Conditions
Non-Hodgkin's LymphomaDiffuse Large B-Cell LymphomaMantle Cell LymphomaFollicular Lymphoma
Interventions
DRUG

SyB L-0501

The administration of SyB L-0501 90 mg/m2 or 120 mg/m2/day on Day 2 and Day 3 will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).

DRUG

Rituximab

The administration of rituximab 375 mg/m2 on Day 1 of each cycle will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).

Trial Locations (4)

Unknown

Nagoya

Isehara

Kyoto

Chuo-ku

Sponsors
All Listed Sponsors
lead

SymBio Pharmaceuticals

INDUSTRY