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

This study has been completed.
Sponsor:
Information provided by:
SymBio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00794638
First received: November 18, 2008
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Diffuse Large B-cell Lymphoma
Mantle Cell Lymphoma
Follicular Lymphoma
Drug: SyB L-0501
Drug: Rituximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by SymBio Pharmaceuticals:

Primary Outcome Measures:
  • Dose-limiting toxicity [ Time Frame: Treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CR rate and the overall response rate, determination by Independent Review Committee [ Time Frame: Treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: November 2008
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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).
    Other Name: Bendamustine hydrochloride
    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).
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794638

Locations
Japan
Nagoya-city, Aichi, Japan
Isehara-city, Kanagawa, Japan
Kyoto-city, Kyoto, Japan
Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
SymBio Pharmaceuticals
Investigators
Study Chair: Kensei Tobinai, MD, Ph D National Cancer Center Hospital
  More Information

No publications provided

Responsible Party: Masahiro Furukawa, SymBio Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00794638     History of Changes
Other Study ID Numbers: 2008002
Study First Received: November 18, 2008
Last Updated: May 27, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by SymBio Pharmaceuticals:
Non-Hodgkin's Lymphoma
Diffuse Large B-Cell Lymphoma
Mantle cell Lymphoma
Transformed lymphoma, transformed to diffuse large B-cell lymphoma
Follicular Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Rituximab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 25, 2014