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

NCT ID: NCT00794638

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-05-31

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

Study Design

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

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Bendamustine hydrochloride

Eligibility Criteria

Inclusion Criteria

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:

1. Diffuse large B-cell lymphoma

2. Mantle cell lymphoma

3. Transformed lymphoma

4. 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

Exclusion Criteria

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

• 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

Responsibility Role: SPONSOR

Principal Investigators

Kensei Tobinai, MD, Ph D

Role: STUDY_CHAIR

National Cancer Center Hospital

Locations

Nagoya, Aichi-ken, Japan

Isehara, Kanagawa, Japan

Kyoto, Kyoto, Japan

Chuo-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

2008002

Identifier Type: -

Identifier Source: org_study_id