Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Condition: Non-Hodgkin's Lymphoma; Lymphoma, Large Cell; Diffuse, Mantle Cell Lymphoma, Lymphoma; Follicular Lymphoma; Large B-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: SyB L-0501; Rituximab
Intervention description: The administration of SyB L-0501 at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule.
SyB L-0501 60 mg/m^2, 90 mg/m^2 or 120 mg/m^2/day on Day 2 and Day 3 will be followed by 18 days of observation.; The administration of rituximab at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Non-Hodgkin's lymphoma; Lymphoma, Large B-Cell; Diffuse, Mantle cell lymphoma, Lymphoma; Follicular, Lymphoma; Large B-Cell, Diffuse

Summary:

      The purpose of this study is to determine the efficacy of SyB L-0501 in combination with
      rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma
             cells

          -  Patients with measurable lesions

          -  Patients with measurable lesions >1.5 cm in major axes

          -  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 38.0°C 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