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 |
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Health condition(s) or Problem(s) studied | mature B-cell lymphoma |
Date of first enrollment | 27/12/2021 |
Target sample size | 100 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | rituximab combined chemotherapy |
Outcome(s)
Primary Outcome | 3-year event free survival rate in intermediate-risk patients under 18-year-old |
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Secondary Outcome | 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 |
Key inclusion & exclusion criteria
Age minimum | >= 6month old |
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Age maximum | < 26age old |
Gender | Both |
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
Primary Sponsor | Sekimizu Masahiro |
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Secondary Sponsor | |
Source(s) of Monetary Support | Japan Agency for Medical Research and Development,Gold Ribbon Network |
Secondary ID(s) |
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 |
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 |
masahiro.sekimizu@nnh.go.jp | |
Affiliation | NHO Nagoya Medical Center |