mature B-cell lymphoma mature B-cell lymphoma
Conditions
Interventions
rituximab
Sponsors
Koh Katsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable. (2) (Low risk) resected Stage I/II, (Intermediate risk) unresected Stage I/II, Stage III with elevated LDH level (LDH <twice the institutional upper limit of the normal values.) (3) 6 months to less than 26 years of age at the time of consent. (4) Newly diagnosed and untreated except for short term steroid (=< 7days) (5) Available for prescribed follow-up and control of therapeutic toxicity. (6) Written informed consent obtained from the patient and/or legally acceptable representatives. (7) Consent to JPLSG-CHM-14 study (3rd edition and above)
Exclusion criteria
Exclusion criteria: (1) PMLBL, Follicular lymphoma, MALT and nodal marginal zone lymphoma (2) Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology. (3) Evidence of pregnancy or lactation period. (4) Exclusion criteria related to rituximab 4-1) Tumor cell negative for CD20 4-2) Prior exposure to rituximab. 4-3) Severe active viral infection, 4-4) Severe uncontrolled infection 4-5) Hepatitis B carrier status history of HBV or positive serology. 5) Judged inappropriate by the doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year event free survival rate in intermediate-risk patients under 18-year-old | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year event free survival rate 3-year oner all survival rate Overall response rate Cumulative relapse rate Adverse events Immune reconstitution assessed by Ig and lymphocyte count | — |
Contacts
Public ContactMasahiro Sekimizu
NHO Nagoya Medical Center
Outcome results
None listed