A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive 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 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.

Official Title
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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

Conditions
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Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma

Intervention / Treatment
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* Drug: SyB L-0501
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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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

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: 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).|
|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity |  | Treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR rate and the overall response rate, determination by Independent Review Committee |  | Treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle cell Lymphoma, Transformed lymphoma, transformed to diffuse large B-cell lymphoma, Follicular Lymphoma