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A Multinational, Multicenter, Open-Label Phase II Study of SyB L-0501 in Combination With Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma


Phase 2
25 Years
75 Years
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Lymphoma, Large Cell, Diffuse, Mantle Cell Lymphoma, Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse

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Trial Information

A Multinational, Multicenter, Open-Label Phase II Study of SyB L-0501 in Combination With Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma


Primary Objective is to determine the efficacy, as measured by overall response rate (ORR)
on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120
mg/m2/day on day2 and 3 in combination with rituximab at 375 mg/m2 on day 1 of each 21-day
cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.


Inclusion Criteria:



- Patients with documented CD20-positive for lymphoma cells

- Patients with measurable lesions

- Relapsed or refractory after 1 to 3 prior therapeutic treatments for diffuse large
B-cell lymphoma.

- Patients who are expected to survive for at least 3 months

- Patients aged from 20 to 75 years at the time informed consent is obtained

- Performance Status (P.S.) of 0 to 1 at initial administration of the study drug

- Patients with adequately maintained organ functions

- Patients capable of personally giving voluntary informed consent in writing to
participate in the study

Exclusion Criteria:

- Patients who have been without treatment for less than 3 weeks after prior treatment

- Patients who can be candidates for autologous peripheral blood stem cell
transplantation at the discretion of the investigator.

- Patients who received adequate prior treatments and did not respond to any of them.

- Patients with central nervous system (CNS) involvement or patients with clinical
symptoms suggestive of CNS involvement.

- Patients with serious, active infections

- Patients with serious complications

- Patients with complications or medical history of serious cardiac disease

- Patients with serious gastrointestinal symptoms

- Patients with malignant pleural effusion, cardiac effusion, or ascites retention

- Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV)
antibody, or HIV antibody

- Patients with serious bleeding tendencies

- Patients with a fever of 38.0C or higher

- Patients with, or confirmed in the past to have had, interstitial pneumonia,
pulmonary fibrosis, or pulmonary emphysema

- Patients with active multiple primary cancer or patients with a history of other
malignant cancer within the past 5 years, except for basal cell cancer of the skin,
squamous cell cancer, or cervical cancer in situ

- Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia

- Patients who received SyB L-0501 in the past

- Patients who received cytokine preparation such as erythropoietin or granulocyte
colony-stimulating factor (G-CSF) or blood transfusions within 2 weeks before the
examination at registration for this study

- Patients who received other investigational products or unapproved medication within
3 months before registration in this study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The Overall Response Rate determined on the basis of Revised Response Criteria for Malignant Lymphoma

Outcome Time Frame:

up to 30 days

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:

2010001

NCT ID:

NCT01118845

Start Date:

May 2010

Completion Date:

March 2012

Related Keywords:

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

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