JPRN-jRCTs041210104
Recruiting
Phase 2
Multicenter clinical trial to evaluate the efficacy of rituximab combination chemotherapy for children or AYAswith localized mature B-cell lymphoma - JPLSG-B-NHL-20
Sekimizu Masahiro0 sites100 target enrollmentNovember 22, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sekimizu Masahiro
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 (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.
Outcomes
Primary Outcomes
Not specified
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