Clinical trial NCT00794638: A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Hodgkin's Lymphoma
Diffuse Large B-Cell Lymphoma
Mantle Cell Lymphoma
Follicular Lymphoma
Keywords: Non-Hodgkin's Lymphoma
Diffuse Large B-Cell Lymphoma
Mantle cell Lymphoma
Transformed lymphoma, transformed to diffuse large B-cell lymphoma
Follicular Lymphoma
Lead sponsor: SymBio Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-11-20
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Dose-limiting toxicity
timeFrame: Treatment period
Secondary outcomes:
measure: CR rate and the overall response rate, determination by Independent Review Committee
timeFrame: Treatment period
Other outcomes:
Locations:
city: Nagoya-city
country: Japan
state: Aichi
city: Isehara-city
country: Japan
state: Kanagawa
city: Kyoto-city
country: Japan
state: Kyoto
city: Chuo-ku
country: Japan
state: Tokyo
Study officials:
affiliation: National Cancer Center Hospital
name: Kensei Tobinai, MD, Ph D
role: STUDY_CHAIR
References: