Efficacy and Safety 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

Conditions

• Low-grade B Cell Non-Hodgkin's Lymphoma
• Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated

Eligibility Criteria

Sex

ALL

Age

20 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• SyB L-0501 — DRUG
  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.
• rituximab — DRUG
  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.

Study Details

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.

Key Dates

Start date

Nov 30, 2011

Status verified

Mar 2016

Primary completion

Nov 30, 2013

Completion

Nov 30, 2013

Study Design

Enrollment

70 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: SyB L-0501＋rituximab

Primary Outcome Measure

Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC) [ Time Frame: Up to 30 weeks ]