Know Cancer

or
forgot password

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


Phase 1
20 Years
75 Years
Not Enrolling
Both
Non-Hodgkin's Lymphoma, Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity

Outcome Time Frame:

Treatment period

Safety Issue:

No

Principal Investigator

Kensei Tobinai, MD, Ph D

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Center Hospital

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

2008002

NCT ID:

NCT00794638

Start Date:

November 2008

Completion Date:

May 2010

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Mantle Cell Lymphoma
  • Follicular Lymphoma
  • Non-Hodgkin's Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Mantle cell Lymphoma
  • Transformed lymphoma, transformed to diffuse large B-cell lymphoma
  • Follicular Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell

Name

Location