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

Phase 1

Completed

• Conditions: Diffuse Large B-Cell Lymphoma; Follicular Lymphoma; Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma

• Registration Number: NCT00794638
• Lead Sponsor: SymBio Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-18
• Study First Submitted QC: 2008-11-19
• Study First Posted: 2008-11-20
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-01
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity	Treatment period

Secondary Outcome Measures

Name	Time	Method
CR rate and the overall response rate, determination by Independent Review Committee	Treatment period