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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794638
• Other study ID #: 2008002
• Status: Completed
• Phase: Phase 1
• Start date: November 2008
• Est. completion date: May 2010

Study information

• Verified date: July 2021
• Source: SymBio Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SymBio Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity		Treatment period
Secondary	CR rate and the overall response rate, determination by Independent Review Committee		Treatment period