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

NCT01118845 | Completed Phase 2 Results DMC

• 1 other identifier: 2010001
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 25

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma

  CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites. For the criteria for CR, See Outcome measure 2 description. The criteria for PR is as below. Nodal Masses: more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site 2. Variably FDG-avid or PET negative; regression on CT Spleen, Liver: more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified

  up to 30 weeks

Secondary Outcomes (15)

• The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma

  up to 30 weeks

• Progression Free Survival (PFS)

  up to 30 weeks

• Number of Subjects With Adverse Event

  up to 30 weeks

• Number of Adverse Events

  up to 30 weeks

• Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values

  up to 30 weeks

Study Arms (1)

SyB L-0501

EXPERIMENTAL

Drug: SyB L-0501; Drug: Rituximab

Interventions

SyB L-0501 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.

Also known as: Bendamustine hydrochloride

SyB L-0501

Rituximab 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.

SyB L-0501

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (25)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Akita, Akita, Japan

Location

Unknown Facility

Matsuyama, Ehime, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Kurume, Fukuoka, Japan

Location

Unknown Facility

Maebashi, Gunma, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Kanazawa, Ishikawa-ken, Japan

Location

Unknown Facility

Kagoshima, Kagoshima-ken, Japan

Location

Unknown Facility

Isehara, Kanagawa, Japan

Location

Unknown Facility

Ninomaru, Kumamoto, Japan

Location

Unknown Facility

Kyoto, Kyoto, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

Unknown Facility

Kita-ku, Okayama-ken, Japan

Location

Unknown Facility

Kurashiki, Okayama-ken, Japan

Location

Unknown Facility

Hidaka, Saitama, Japan

Location

Unknown Facility

Izumo, Shimane, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Unknown Facility

Seo-gu, Busan, South Korea

Location

Unknown Facility

Jung-gu, Daegu, South Korea

Location

Unknown Facility

Goyang-si, Gyeonggi-do, South Korea

Location

Unknown Facility

Hwasun-gun, Jeollanam-do, South Korea

Location

Unknown Facility

Gangnam-gu, Seoul, South Korea

Location

Unknown Facility

Seodaemun-gu, Seoul, South Korea

Location

Unknown Facility

Songpa-gu, Seoul, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Dendritic Cell Sarcoma, Interdigitating; Lymphoma, Mantle-Cell; Lymphoma; Lymphoma, Follicular

Interventions

Bendamustine Hydrochloride; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Histiocytic Disorders, Malignant; Histiocytosis

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Toshihiko Nagase
• Organization: Symbio Pharmaceuticals

tnagase.331@symbiopharma.com

81-3-5472-1127

Study Officials

• Kensei Tobinai, MD, Ph D

  National Cancer Center Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 1, 2010
• First Posted: May 7, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 4, 2013
• Results First Posted: July 4, 2013

Record last verified: 2013-05

Locations

KR (7); JP (18)