Multicenter clinical trial to evaluate the efficacy of rituximab combination chemotherapy for children or AYAswith localized mature B-cell lymphoma

Phase 2

Recruiting

Conditions: mature B-cell lymphoma
D008223

Registration Number: JPRN-jRCTs041210104

Lead Sponsor: Sekimizu Masahiro

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

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 (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

(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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year event free survival rate in intermediate-risk patients under 18-year-old

Secondary Outcome Measures

Name	Time	Method
3-year event free survival rate<br>3-year oner all survival rate <br>Overall response rate<br>Cumulative relapse rate<br>Adverse events<br>Immune reconstitution assessed by Ig and lymphocyte count