Last updated on November 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lymphoma | B-cell | Diffuse
  • Age: Between 20 - 79 Years
  • Gender: Male or Female

For previously untreated patients with Lg-B-NHL or MCL

Inclusion Criteria

Patients who satisfy all of the conditions listed below:

Patients who satisfy all of the following criteria A) to D): A) Patients who are histopathologically confirmed to have one of the following subtypes of CD20 (cluster of differentiation 20)-positive Lg-B-NHL or MCL (excluding transformed lymphoma) by lymph node biopsy or evaluable tissue biopsy (World Health Organization [WHO] histological classification [4th edition]).

  • Small lymphocytic lymphoma
  • Splenic marginal zone lymphoma
  • Lymphoplasmacytic lymphoma
  • Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT)
  • Nodal marginal zone lymphoma
  • Follicular lymphoma (Grade 1, 2, 3a)
  • MCL B) Patients who have at least one measurable lesion (>1.5 cm in major axis on computed tomography [CT]). C) Patients without a history of treatment for lymphoma. D) Patients with at least one of the following clinical signs or symptoms (with the exception of MCL patients).
    1. Bulky disease >7 cm in major axis on CT (excluding lesions in the spleen)
    2. B symptoms
  • Unexplained fever exceeding 38.0C
  • Night sweats
  • Weight loss of more than 10% within 6 months before registration 3. Elevated serum lactate dehydrogenase (LDH) or 2-microglobulin level 4. Involvement of at least 3 regional lymph nodes >3 cm in major axis on CT 5. Symptomatic splenomegaly 6. Compressive symptoms 7. Pleural effusion and/or ascites
  • Patients aged between 20 and 79 years (at the time of registration).
  • Patients who are expected to survive for at least 3 months.
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
  • Patients with adequate functional reserve of major organs (bone marrow, heart, lungs, liver, kidneys, etc.).
  • Neutrophil count: 1,500/mm^3
  • Platelet count: 75,000/mm^3
  • Aspartate aminotransferase (AST) [glutamic oxaloacetic transaminase [GOT]): 3.0 times the institution's upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) [glutamic pyruvic transaminase (GPT)]: 3.0 times the institution's ULN
  • Total bilirubin: <2.0 mg/dL
  • Serum creatinine: <2.0 mg/dL
  • Percutaneous arterial oxygen saturation (SpO2): 95% or Partial arterial oxygen pressure (PaO2): 65 mmHg
  • No abnormal findings requiring treatment on electrocardiogram (ECG)
  • Left ventricular ejection fraction (LVEF) on echocardiography: 55%
  • Patients who have provided written informed consent to participate in this study.

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 38.0C 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 colonystimulating 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

Inclusion Criteria

Patients who satisfy all of the conditions listed below:

Patients who satisfy both of the following criteria A and B: A) Patients who are histopathologically confirmed to have CD20-positive DLBCL (excluding transformed lymphoma) by lymph node biopsy or evaluable tissue biopsy (WHO histological classification [4th edition]).

B) Patients with recurrent or refractory DLBCL who have had disease progression after standard rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP) therapy or R-CHOP-like therapy as first-line treatment.

  • Patients aged between 20 and 79 years (at the time of registration).
  • Patients who are expected to survive for at least 3 months.
  • Patients with an ECOG PS of 0 to 2.
  • Patients with adequate functional reserve of major organs (bone marrow, heart, lungs, liver, kidneys, etc.).
  • Neutrophil count: 1,500/mm^3
  • Platelet count: 75,000/mm^3
  • AST (GOT): 3.0 times the institution's ULN
  • ALT (GPT): 3.0 times the institution's ULN
  • Total bilirubin: <2.0 mg/dL
  • Serum creatinine: <2.0 mg/dL
  • SpO2: 95% or PaO2: 65 mmHg
  • No abnormal findings requiring treatment on ECG
  • LVEF on echocardiography: 55%
  • Patients who have provided written informed consent to participate in this study.

Exclusion Criteria

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 38.0C 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.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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