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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: bendamustine hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bendamustine hydrochloride|1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All adverse events or adverse reactions, during the treatment cycle (twenty one days) |  |  | 
| Pharmacokinetics profile |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Hodgkin's Lymphoma, Malignant lymphoma