A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-Cell Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by:
SymBio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00389051
First received: October 16, 2006
Last updated: August 20, 2007
Last verified: May 2007
  Purpose

The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell Non-Hodgkin's Lymphoma.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: bendamustine hydrochloride
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, Open Study to Assess the Tolerability, Pharmacokinetics and Antitumor Effect of Bendamustine Hydrochloride (SyB L-0501: 90 or 120 mg/m2/Day) Administered Intravenously for Two Days in Patients With Indolent Lymphoma

Resource links provided by NLM:


Further study details as provided by SymBio Pharmaceuticals:

Primary Outcome Measures:
  • Hematological toxicity; > grade four (CTCAE v.3.0), during the treatment cycle (twenty one days)
  • Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)

Secondary Outcome Measures:
  • All adverse events or adverse reactions, during the treatment cycle (twenty one days)
  • Pharmacokinetics profile

Estimated Enrollment: 12
Study Start Date: October 2006
Estimated Study Completion Date: September 2007
Detailed Description:

Indolent B-cell Non-hodgkin's lymphoma is treated mainly with radiation and chemotherapy using a combination of chemotherapies, such as purine-analogues and CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone). After the approval of an antibody therapy agent Rituximab®, it alone or combination with CHOP has been introduced. Bendamustine hydrochloride has a unique structure compared with the marketed agents, and has an innovative mechanism of action. Thus, it is expected that Bendamustine hydrochloride will provide new alternatives for patients with indolent B-cell Non-hodgkin's lymphoma.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Indolent B cell Non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.

  • Patients with histologically or cytologically confirmed indolent B cell Non-Hodgkin's lymphoma.
  • Patients who had not received treatment (chemotherapy, antibody therapy and radiation/ radiotherapy) for more than 4 weeks following prior therapy and who are judged to carry no effect from the prior therapy.
  • Patients aged from 20 to less than 75 years.
  • Patients who had agreed in-patient during first course therapy.
  • Patients from whom written consent to participate in this study has been obtained.

Exclusion Criteria:Patients who meet any of the following criteria will be excluded.

  • Patients with apparent infections.
  • Patients with serious complications (hepatic failure or renal failure).
  • Patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease).
  • Patients with serious digestive symptoms (nausea/ vomiting/ diarrhea).
  • Patients who are known to be positive for HBV, HCV or HIC.
  • Patients receiving other investigational drugs within 3 months before registration in the study.
  • Patients with allogenic transplant.
  • Women who are pregnant, of childbearing potential, or lactating.
  • Patients who do not agree to contraception.
  • Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
  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: NCT00389051

Locations
Japan
Kanagawa, Japan
Kyoto, Japan
Nagoya, Japan
Tokyo, Japan
Sponsors and Collaborators
SymBio Pharmaceuticals
Investigators
Study Chair: Kensei Tobinai, MD, PhD National Cancer Center Hospital
  More Information

No publications provided by SymBio Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00389051     History of Changes
Other Study ID Numbers: 2006001
Study First Received: October 16, 2006
Last Updated: August 20, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by SymBio Pharmaceuticals:
Non-Hodgkin's Lymphoma
Malignant lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014