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

Sponsored by:	SymBio Pharmaceuticals
Information provided by:	SymBio Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00389051

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 I

MedlinePlus related topics: Lymphoma

Drug Information available for: Bendamustine Bendamustine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389051

Locations

Japan

Tokyo, Japan

Kanagawa, Japan

Nagoya, Japan

Kyoto, Japan

Sponsors and Collaborators

SymBio Pharmaceuticals

Investigators

Study Chair:

Kensei Tobinai, MD, PhD

National Cancer Center Hospital

More Information

Study ID Numbers:	2006001
Study First Received:	October 16, 2006
Last Updated:	August 20, 2007
ClinicalTrials.gov Identifier:	NCT00389051
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by SymBio Pharmaceuticals:

Non-Hodgkin's Lymphoma
Malignant lymphoma

Study placed in the following topic categories:

Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
Mechlorethamine
B-cell lymphomas
Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Nitrogen Mustard Compounds
Bendamustine

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009