Indolent B cell Non-Hodgkin'
Conditions
Interventions
BM-ca 5mg/Kg 1/week x4week
BM-ca 10mg/Kg 1/week x4week
BM-ca 15mg/Kg 1/week x4week
Sponsors
Biomedics Japan Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged from 20 to 74 2) Zero or 1 of Performance Status (ECOG) 3) CD20 positive in lymphoma cell 4) Refractory to or relapsed after Rituximab therapy 5) Extended more than 12 weeks from the latest Rituximab infusion and extended more than 4 weeks from the other therapeutic treatments 6) Expected more than three months of survival period 7) At least one measurable lesion with > 15 mm end of volume 8) No history of higher concentration of steroid treatment for more than 4 weeks prior to first infusion 9) Adequate organ function a.Hemoglobin > 10g/dL b.Platelet count > 75000/microL c.Neutrophil count>1500/mm3 d.Creatinine < 1.5X upper limit of normal e.Bilirubin < 1.5X upper limit of normal f.ALT <2.5X upper limit of normal 10) Signed in an informed consent for participating to this study
Exclusion criteria
Exclusion criteria: 1) Presence or suspicion of CNS involvement 2) History of congestive heart failure, any other clinical or psychiatric diagnoses which affect to outcomes of this study, as concomitant malignancies in other organs within 5 years 3) Regarding to the safety a.Positive to HBs antigen, HBc, HCV and HIV antibodies b.Concomitant cardiovascular or lung, hematologic diseases c.History of any other malignancies other than lymphoma within 5 years d.Serious mental disorder e.Pregnant including suspicious or lactating, or no willing to contraception until further 6 months after final infusion. f.Entry to other clinical study at least four months prior to the entry into this study g.Allergy to pharmaceuticals of proteins h.Suspicious transformation to aggressive lymphomas i.History of autologous haematopoietic stem cell transplantation j.diagnosed as ineligible to be entered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is to evaluate safety of BM-ca therapy from any adverse events and dose limiting toxicities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome is to evaluate efficacy of BM-ca therapy from Overall Response Rate, Progression-Free Survival and Response Duration. Another outcome is to test Pharmacokinetics parameters. | — |
Countries
Japan
Outcome results
None listed