A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma

Sponsor

SymBio Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00794638

Collaborator

(none)

Enrollment

Locations

17.9

Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma Diffuse Large B-Cell Lymphoma Mantle Cell Lymphoma Follicular Lymphoma	Drug: SyB L-0501 Drug: Rituximab	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

May 1, 2010

Outcome Measures

Primary Outcome Measures

Dose-limiting toxicity [Treatment period]

Secondary Outcome Measures

CR rate and the overall response rate, determination by Independent Review Committee [Treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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