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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
SyB L-0501
Rituximab
Sponsored by
SymBio Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle cell Lymphoma, Transformed lymphoma, transformed to diffuse large B-cell lymphoma, Follicular Lymphoma

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Dose-limiting toxicity

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2008
Last Updated
July 1, 2021
Sponsor
SymBio Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00794638
Brief Title
A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SymBio Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SyB L-0501
Other Intervention Name(s)
Bendamustine hydrochloride
Intervention Description
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
Intervention Name(s)
Rituximab
Intervention Description
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).
Primary Outcome Measure Information:
Title
Dose-limiting toxicity
Time Frame
Treatment period
Secondary Outcome Measure Information:
Title
CR rate and the overall response rate, determination by Independent Review Committee
Time Frame
Treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kensei Tobinai, MD, Ph D
Organizational Affiliation
National Cancer Center Hospital
Official's Role
Study Chair
Facility Information:
City
Nagoya-city
State/Province
Aichi
Country
Japan
City
Isehara-city
State/Province
Kanagawa
Country
Japan
City
Kyoto-city
State/Province
Kyoto
Country
Japan
City
Chuo-ku
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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