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

July 1, 2021 updated by: SymBio Pharmaceuticals

A Multicenter Phase I Clinical Trial to Assess the Safety of Two Consecutive Days of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- Aichi
  - Nagoya-city, Aichi, Japan
- Kanagawa
  - Isehara-city, Kanagawa, Japan
- Kyoto
  - Kyoto-city, Kyoto, Japan
- Tokyo
  - Chuo-ku, Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose-limiting toxicity Time Frame: Treatment period	Treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
CR rate and the overall response rate, determination by Independent Review Committee Time Frame: Treatment period	Treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SymBio Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

November 18, 2008

First Submitted That Met QC Criteria

November 19, 2008

First Posted (ESTIMATE)

November 20, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified