Follicular lymphoma
Conditions
Interventions
A: Watchful waiting. When at least one of the following (i) to (iii) is fulfilled, 1 cycle of rituximab at 375 mg/m2 on day1, 8, 15, and 22 is administered. (i) more than 5 cm and less than 7 cm in t
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Follicular lymphoma (Grade1, 2 and 3A) with CD20 positive. 2) Ann Arbor CS III and IV diagnosed by CT and bone marrow examination within 56 days before entry 3) The following (i) to (vi) are fulfilled by physical findings and CT within 56 days before entry (i) Largest nodal or extra nodal mass less than 5cm (ii) Two or less nodal sites with a diameter of 3cm or more (iii) The absence of B symptoms (iv) Spleen size is less than 16cm by CT (v) No significant serous effusions (vi) No critical organ compression 4) Aged 20 to 80 years old 5) ECOG performance status (PS) of 0 or 1 6) Bidimensionally measurable disease >1.5cm in a single dimention by CT 7) No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy 8) Patients with sufficient organ functions 9) Written informed consent
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. Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. 4. Severe psychological disorder. 5. Receiving continuous systemic corticosteroid or immunosuppressant treatment. 6. Insulin-dependent or uncontrollable diabetes mellitus 7. Uncontrollable hypertension 8. Unstable angina pectoris, or history of myocardial infarction within six months. 9. HBs-Ag positive or HCV-Ab positive 10. HBs-Ab positive or HBc-Ab positive with HBV DNA levels of 2.1 log copies/mL or more 11. Positive HIV antibody 12. Uncontrollable glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| cytotoxic therapy-free survival, histological transformation-free survival, overall survival, progression-free survival, response proportion, adverse events, severe adverse events. | — |
Countries
Japan
Contacts
Public ContactFukuhara Noriko
JCOG1411Coordinating Office Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine
Outcome results
None listed