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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041210104

Registered date:22/11/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedmature B-cell lymphoma
Date of first enrollment27/12/2021
Target sample size100
Countries of recruitment
Study typeInterventional
Intervention(s)rituximab combined chemotherapy

Outcome(s)

Primary Outcome3-year event free survival rate in intermediate-risk patients under 18-year-old
Secondary Outcome3-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

Key inclusion & exclusion criteria

Age minimum>= 6month old
Age maximum< 26age old
GenderBoth
Include 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)
Exclude 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

Related Information

Contact

Public contact
Name Masahiro Sekimizu
Address 4-1-1, Sannomaru, Naka-ku Nagoya-shi, Aichi Aichi Japan 460-0001
Telephone +81-52-951-1111052-951-0664
E-mail masahiro.sekimizu@nnh.go.jp
Affiliation NHO Nagoya Medical Center
Scientific contact
Name Masahiro Sekimizu
Address 4-1-1, Sannomaru, Naka-ku Nagoya-shi, Aichi Aichi Japan 460-0001
Telephone +81-52-951-1111
E-mail masahiro.sekimizu@nnh.go.jp
Affiliation NHO Nagoya Medical Center