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

NCT00794638 | Completed Phase 1 DMC

• 1 other identifier: 2008002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended dose for the Phase II clinical trial.

Conditions

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

Keywords

Non-Hodgkin's Lymphoma; Diffuse Large B-Cell Lymphoma; Mantle cell Lymphoma; Transformed lymphoma, transformed to diffuse large B-cell lymphoma; Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity

  Treatment period

Secondary Outcomes (1)

• CR rate and the overall response rate, determination by Independent Review Committee

  Treatment period

Interventions

SyB L-0501 DRUG

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).

Also known as: Bendamustine hydrochloride

Rituximab DRUG

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).

Eligibility Criteria

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

You may qualify if:

• Aggressive B-cell non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.
• Patients with the following histologically confirmed CD20(+) B-cell non-Hodgkin's lymphoma:
• Diffuse large B-cell lymphoma
• Mantle cell lymphoma
• Transformed lymphoma
• Follicular lymphoma (Grade 3)
• Fail to CR in prior chemotherapy, or relapse following CR or recurrence following PR.
• Patients who are judged to carry no effect from the prior therapy (cancer chemotherapy, antibody therapy and radiation/ radiotherapy.
• Patients aged from 20 to 75 years at the time informed consent is obtained
• Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)
• Patients who can be hospitalized during the first cycle
• Patients capable of personally giving voluntary informed consent in writing to participate in the study

You may not qualify if:

• Patients who meet any of the following criteria will be excluded.
• Patients with serious complications (hepatic or renal failure)
• Patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease)
• Patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
• Patients positive for HBs antigen, HCV antibody, or HIV antibody
• Patients who received other investigational drug or unapproved medication within 3 months before registration in this study
• Patients who had history of hematopoietic stem cell transplantation or radioimmunotherapy
• Patients who are pregnant, of childbearing potential, or lactating
• Patients, whether male or female, who do not agree to contraception
• Patients otherwise judged by investigator or sub investigator to be unsuitable

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (4)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Isehara, Kanagawa, Japan

Location

Unknown Facility

Kyoto, Kyoto, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

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

Interventions

Bendamustine Hydrochloride; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

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

Study Officials

• Kensei Tobinai, MD, Ph D

  National Cancer Center Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 20, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 2, 2021

Record last verified: 2021-07

Locations

JP (4)