Untreated patients with CD20 positive indolent B-cell non-Hodgkin'
Conditions
Interventions
In the induction phase, patients have to respond to 6 cycles of R-CHOP and 2 infusions of IDEC-C2B8 in order to move to the maintenance phase. After the maintenance period, patients will be followed-u
Sponsors
Zenyaku Kogyo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Confirmed CD20 positive indolent NHL 2)Patients previously untreated with chemotherapy immunotherapy, immunochemotherapy, immunoradiotherapy. 3)Patients with at least one of the following signs or symptoms requiring initiation of treatment: i)Bulky disease at study entry: nodal or extra-nodal mass (except spleen) > 7cm in its greater diameter ii)B symptoms iii)Elevated serum LDH or beta2-microglobulin iv)involvement of at least 3 nodal sites (each with a diameter greater than 3 cm) v)symptomatic splenic enlargement vi)Compressive syndrome vii)Pleural/peritoneal effusion - Life expectancy > 6 months. 4)Performance status < 2 on the ECOG scale. 5)Patients between 20 years and 80 years. 6)Adequate organ function within 28 days i) Hematological function -Absolute neutrophil counts > 1,500/uL -Platelet conts > 100,000/uL -Hemoglobin > 8.0g/dL ii) Hepatic function -AST < 3.0 x the upper limit of normal -ALT < 3.0 x the upper limit of normal -Total bilirubin < 2.0 mg/dL iii) Renal function -Serum creatinine < 2.0 mg/dL iv) Cardiac function -LVEF > 50% -PaO2 > 65 mmHg 7)Hospitalization 8)Patients who signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1)Treatment history i)With a history of other monoclonal antibody treatment. ii)Have participated in other clinical trial(s) for unapproved agent or treated with unapproved indication within 6 months prior to registration iii)Who received G-CSF within 7days prior to trial entry iv)With a history of sensitive or allergic to murine-derived materials v)Having received major surgery (excluding lymph node biopsy) within 28 days prior to registration 2)Follicular lymphoma Grade 3b 3)Tumor cells in peripheral blood > 10,000/uL 4)Co-existing medical conditions or previous disease i)Known HIV infection ii)Known active HBV or HCV infection and/or known positive in any one of HBs antigen, HBs antibody, HBc antibody or HCV antibody by laboratory tests within 28 days prior to registration 5)Patients with infections and serious underlying medical conditions which could impair the ability of the patient to participate in the trial 6)Patients who routinely use insulin by self injection. 7)Patients with prior or concomitant malignancies 8)Presence or history of CNS lymphoma infiltration 9)Serious psychological conditions 10)Women who are pregnant, breast feeding or positive of pregnant test. 11)Women and men who do not agree to use effective contraception during participation in the trial and for 12 months thereafter.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) rate at the years of 4 (4-yr PFS rate). | — |
Countries
Japan
Contacts
Public ContactTsunehiko Ito
Zenyaku Kogyo Co., Ltd. Clinical Development
Outcome results
None listed