Phase I/II Study of SyB L-0501RI in Combination With Rituximab to Treat Lymphoma

Exclusion Criteria

• •Patients who meet any of the following conditions will be excluded:
• •MCL patients aged ≤65 years (at the time of registration).
• •Patients who have a history of treatment for Lg-B-NHL or MCL (chemotherapy, radiotherapy, antibody therapy or antitumor steroid therapy).
• •Patients who have previously received hematopoietic stem cell transplantation.
• •Patients with invasion to central nervous system (CNS) or clinical symptoms suspected of CNS invasion.
• •Patients with serious active infection (requiring antibiotic, antifungal, or antiviral IV injection).
• •Patients with serious complications (such as hepatic failure and renal failure).
• •Patients with concurrent or previous, serious cardiac disease (e.g., myocardial infarction, ischemic heart disease); however, patients with arrhythmias are allowed to be enrolled if it does not require treatment at the time of registration.
• •Patients with serious gastrointestinal symptoms (such as high-grade or severe nausea/vomiting or diarrhea).
• •Patients with malignant pleural effusion, pericardial effusion, or ascites.
• •Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody (patients with positive hepatitis B virus \[HBV\]-DNA quantitative test results if they are negative for HBs antigen and positive for HBs antibody or hepatitis B core \[HBc\] antibody).
• •Patients with serious bleeding tendencies (such as disseminated intravascular coagulation \[DIC\]).
• •Patients with a fever of 38.0ºC or higher (with the exception of fever developing as a B symptom).
• •Patients with concurrent or previous interstitial pneumonia, pulmonary fibrosis, or chronic obstructive pulmonary disease.
• •Patients with active multiple primary cancers or patients with a history of other malignancy within the past 5 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or digestive organs.
• •Patients with concurrent or previous autoimmune hemolytic anemia.
• •Patients who have previously received bendamustine hydrochloride.
• •Patients who have received a cytokine preparation, such as granulocyte colony- stimulating factor (G-CSF) or erythropoietin, or blood transfusions within 2 weeks before a screening test for this study.
• •Patients who have received other investigational products or unapproved drugs within 3 months before registration for this study.
• •Patients with a history of allergy to medications similar to SyB L-0501RI (e.g., alkylating agents and purine-nucleoside derivatives).
• •Patients who cannot tolerate rituximab.
• •Pregnant, possibly pregnant, or lactating women.
• •Patients, whether male or female, who do not agree to use contraception.
• •Duration:
• •Male patients; during the treatment period and for 6 months after treatment Female patients with no menstruation; during the treatment period Female patients with menstruation; during the treatment period and for 3 months after treatment
• •Patients with drug addiction, narcotic addiction, or alcohol dependence.
• •Patients who are unable to take pre-treatment medication due to drug allergies or the like.
• •Patients who are otherwise judged by the investigator or subinvestigator to be unsuitable as a subject.
• •For patients with recurrent or refractory DLBCL
• •Patients who meet any of the following conditions will be excluded:
• •Patients with an off-treatment interval of less than 3 weeks between the last day of preceding treatment (chemotherapy, radiotherapy, antibody therapy, or antitumor steroid therapy) for DLBCL and the day of registration for this study.
• •Patients who are judged by the investigator or subinvestigator to be suitable for autologous peripheral blood stem cell transplantation.
• •Patients who have previously received allogeneic hematopoietic stem cell transplantation.
• •Patients who have previously received radioimmunotherapy
• •Patients with invasion to CNS or clinical symptoms suspected of CNS invasion.
• •Patients with serious active infection (requiring antibiotic, antifungal, or antiviral IV injection).
• •Patients with serious complications (such as hepatic failure and renal failure).
• •Patients with concurrent or previous, serious cardiac disease (e.g., myocardial infarction, ischemic heart disease); however, patients with arrhythmias are allowed to be enrolled if it does not require treatment at the time of registration.
• •Patients with serious gastrointestinal symptoms (such as high-grade or severe nausea/vomiting or diarrhea).
• •Patients with malignant pleural effusion, pericardial effusion, or ascites.
• •Patients positive for HBs antigen, HCV antibody, or HIV antibody (patients with positive HBV-DNA quantitative test results if they are negative for HBs antigen and positive for HBs antibody or HBc antibody).
• •Patients with serious bleeding tendencies (such as DIC).
• •Patients with a fever of 38.0ºC or higher (with the exception of fever developing as a B symptom).
• •Patients with concurrent or previous interstitial pneumonia, pulmonary fibrosis, or chronic obstructive pulmonary disease.
• •Patients with active multiple primary cancers or patients with a history of other malignancy within the past 5 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or digestive organs.
• •Patients with concurrent or previous autoimmune hemolytic anemia.
• •Patients who have previously received bendamustine hydrochloride.
• •Patients who have received a cytokine preparation, such as G-CSF or erythropoietin, or blood transfusions within 2 weeks before a screening test for this study.
• •Patients who have received other investigational products or unapproved drugs within 3 months before registration for this study.
• •Patients with a history of allergy to medications similar to SyB L-0501RI (e.g., alkylating agents and purine-nucleoside derivatives).
• •Patients who cannot tolerate rituximab.
• •Pregnant, possibly pregnant, or lactating women.
• •Patients, whether male or female, who do not agree to use contraception.
• •Duration:
• •Male patients; during the treatment period and for 6 months after treatment Female patients with no menstruation; during the treatment period Female patients with menstruation; during the treatment period and for 3 months after treatment
• •Patients with drug addiction, narcotic addiction, or alcohol dependence.
• •Patients who are unable to take pre-treatment medication due to drug allergies or the like.
• •Patients who are otherwise judged by the investigator or subinvestigator to be unsuitable as a subject.