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

SymBio Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Non-Hodgkin's Lymphoma

Follicular Lymphoma

Mantle Cell Lymphoma

Diffuse Large B-Cell Lymphoma

Treatments

Drug: SyB L-0501

Drug: Rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00794638

2008002

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No 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:
1. Diffuse large B-cell lymphoma
2. Mantle cell lymphoma
3. Transformed lymphoma
4. 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