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Completed

NCT Number: NCT00794638

A Phase I Clinical Trial 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.

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Key information

Conditions

Non-Hodgkin's Lymphoma Diffuse Large B-cell Lymphoma Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma Neoplasms Neoplasms by Histologic Type

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: 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).

Primary outcomes

  1. Dose-limiting toxicity

    Time frame: Treatment period

Secondary outcomes

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

    Time frame: Treatment period

Sponsors and collaborators

Lead sponsor

SymBio Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 20, 2008
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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