Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT ID: NCT01118845

Last Updated: 2013-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-10-31

Brief 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.

Detailed Description

Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m^2/day on day2 and 3 in combination with rituximab at 375 mg/m^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.

Conditions

Non-Hodgkin's Lymphoma; Lymphoma, Large Cell; Diffuse, Mantle Cell Lymphoma, Lymphoma; Follicular Lymphoma; Large B-Cell, Diffuse

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SyB L-0501

Group Type: EXPERIMENTAL

SyB L-0501

Intervention Type: DRUG

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.

Rituximab

Intervention Type: DRUG

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.

Interventions

SyB L-0501

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.

Intervention Type: DRUG

Rituximab

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.

Intervention Type: DRUG

Other Intervention Names

Bendamustine hydrochloride

Eligibility Criteria

Inclusion Criteria

• Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells
• Patients with measurable lesions
• Patients with measurable lesions >1.5 cm in major axes
• Relapsed or refractory after 1 to 3 prior therapeutic treatments for diffuse large B-cell lymphoma.
• Patients who are expected to survive for at least 3 months
• Patients aged from 20 to 75 years at the time informed consent is obtained
• Performance Status (P.S.) of 0 to 1 at initial administration of the study drug
• Patients with adequately maintained organ functions
• Patients capable of personally giving voluntary informed consent in writing to participate in the study

Exclusion Criteria

• Patients who have been without treatment for less than 3 weeks after prior treatment
• Patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator.
• Patients who received adequate prior treatments and did not respond to any of them.
• Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement.
• Patients with serious, active infections
• Patients with serious complications
• Patients with complications or medical history of serious cardiac disease
• Patients with serious gastrointestinal symptoms
• Patients with malignant pleural effusion, cardiac effusion, or ascites retention
• Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody
• Patients with serious bleeding tendencies
• Patients with a fever of 38.0°C or higher
• Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema
• Patients with active multiple primary cancer or patients with a history of other malignant cancer within the past 5 years, except for basal cell cancer of the skin, squamous cell cancer, or cervical cancer in situ
• Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia
• Patients who received SyB L-0501 in the past
• Patients who received cytokine preparation such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) or blood transfusions within 2 weeks before the examination at registration for this study
• Patients who received other investigational products or unapproved medication within 3 months before registration in this study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SymBio Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

SymBio Pharmaceuticals Limited

Principal Investigators

Kensei Tobinai, MD, Ph D

Role: STUDY_CHAIR

National Cancer Center Hospital

Locations

Nagoya, Aichi-ken, Japan

Akita, Akita, Japan

Matsuyama, Ehime, Japan

Fukuoka, Fukuoka, Japan

Kurume, Fukuoka, Japan

Maebashi, Gunma, Japan

Sapporo, Hokkaido, Japan

Kanazawa, Ishikawa-ken, Japan

Kagoshima, Kagoshima-ken, Japan

Isehara, Kanagawa, Japan

Ninomaru, Kumamoto, Japan

Kyoto, Kyoto, Japan

Sendai, Miyagi, Japan

Kita-ku, Okayama-ken, Japan

Kurashiki, Okayama-ken, Japan

Hidaka, Saitama, Japan

Izumo, Shimane, Japan

Chuo-ku, Tokyo, Japan

Seo-gu, Busan, South Korea

Jung-gu, Daegu, South Korea

Goyang-si, Gyeonggi-do, South Korea

Hwasun-gun, Jeollanam-do, South Korea

Gangnam-gu, Seoul, South Korea

Seodaemun-gu, Seoul, South Korea

Songpa-gu, Seoul, South Korea

Countries

Japan; South Korea

Other Identifiers

2010001

Identifier Type: -

Identifier Source: org_study_id