Untreated, advanced-stage high tumor burden follicular lymphoma
Conditions
Interventions
Induction therapy:OB therapy
Course 1
Obinutuzumab 1,000 mg/body (day 1,8,15)+Bendamustine 90 mg/m2 (day 1,2)
Course 2-6
Obinutuzumab 1,000 mg/body (day 1)+Bendamustine 90 mg/m2 (day 1,2), every 4 wee
Sponsors
FUKUHARA Noriko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary registration criteria (1) Follicular lymphoma (Grade1, 2 or 3A) with CD20 positive. (2) Ann Arbor CS II, III or IV diagnosed by CT and bone marrow examination. (3) Any of the following (i) to (viii) are fulfilled by physical findings and CT within 56 days before entry (i) Largest nodal or extra nodal mass more than 7cm (ii) More then three nodal sites with a diameter of 3cm or more (iii) Lymphoma cell in peripheral blood more than 5000/mm3 (iv) The presence of B symptoms (v) Spleen size is more than 16cm by CT (vi) Massive serous effusions (vii) Critical organ compression (viii) Cytopenia due to lymphomatous bone marrow involvement(fullfills one or more of the following three) * The presence or absence of bone marrow infiltration is determined in 3.3.1.2)(iv) . * Absolute neutrophil count < 1000/mm3 Hemoglobin concentration < 10 g/dL Absolute platelet count < 100000/mm3 (4) Aged 20 or older (5) ECOG performance status (PS) of 0 to 2 (6) Measurable lesions (7) No CNS involvement on clinical diagnosis (spinal fluid studies and brain MRI are not always necessary). (8) No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy (9) Patients with sufficient organ functions * The presence or absence of bone marrow infiltration is determined in 3.3.1.2)(iv) . (10) Written informed consent Secondary registration criteria (1) Primary registration for this trial (2) Following (i) or (ii) is satisfied. (i)OB therapy (6 courses) was completed and CMR was obtained by FDG-PET/ CT (ii)OB therapy (only 4 or 5 courses) was completed due to adverse events and CMR was obtained by FDG-PET/CT (3)No Grade 2 or higher non-hematological toxicity (4)ECOG performance status (PS) of 0 to 1 (5)Patients with sufficient organ functions (6)Within 42-98 days from the last administration of OB therapy
Exclusion criteria
Exclusion criteria: (1) Synchronous double or multiple cancer or metachronous double or multiple cancer with progression free period less than 5 years. (2) Infectious disease requiring systemic treatment. (3) A fever over 38 degrees (except when infection or drug fever can be ruled out) (4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. (5) Severe psychological disorder. (6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. (7) Uncontrollable diabetes mellitus (8) Uncontrollable hypertension (9) Unstable angina pectoris, or history of myocardial infarction within six months. (10) HBs-Ag positive or HCV-Ab positive (11) HBs-Ab positive or HBc-Ab positive with HBV DNA levels of 20 IU/mL (1.3 logIU/mL) or more (12) Positive HIV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS:progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| OS:overall survival TTNT:time to next treatment POD24:progression of disease within 24 months ORR:overall response rate CRR:complete response rate CMRR:complete metabolic response rate adverse events severe adverse events histological/clinical transformation | — |
Contacts
Public ContactNoriko FUKUHARA
Tohoku University Hospital
Outcome results
None listed