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Clinical Trials/JPRN-jRCTs041210104
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.

Registry
who.int
Start Date
November 22, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sekimizu Masahiro

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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