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

November 18, 2008
May 27, 2010
November 2008
March 2010   (final data collection date for primary outcome measure)
Dose-limiting toxicity [ Time Frame: Treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00794638 on ClinicalTrials.gov Archive Site
CR rate and the overall response rate, determination by Independent Review Committee [ Time Frame: Treatment period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Hodgkin's Lymphoma
  • Diffuse Large B-cell Lymphoma
  • Mantle Cell Lymphoma
  • Follicular Lymphoma
  • 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).
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
May 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00794638
2008002
Yes
Masahiro Furukawa, SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals
Not Provided
Study Chair: Kensei Tobinai, MD, Ph D National Cancer Center Hospital
SymBio Pharmaceuticals
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP