Multi-center Trial for Children with B-cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients.

JRCT ID: jRCTs041180089

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: B-cell NHL or Mature B-cell Acute Leukemia
• Date of first enrollment: 15/06/2016
• Target sample size: 46
• Study type: Interventional
• Intervention(s): The patients will receive a total of 6 injections of the antibody: 2 at 48h interval at D-2 and D1 of the 2 COPADM courses and one injection at D1 of the 2 consolidation courses either CYM (B) or CYVE (C1 or C3). Rituximab is given at the dose of 375 mg/m2 I.V.

Outcome(s)

• Primary Outcome: Event free survival

Secondary Outcome

1)Survival
2)Complete remission rate
3)Acute and long term toxicity
4)Immune reconstitution assessed by immunogloburin level and lymphocyte counts

Key inclusion & exclusion criteria

• Age minimum: >= 06month old
• Age maximum: < 216month old
• Gender: Both

Include criteria

(1) Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable.
(2) Stage III with elevated LDH level, (LDH > twice the institutional upper limit of the adult normal values) or any stage IV or B-AL.
(3) 6 months to less than 18 years of age at the time of consent.
(4) Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate.
(5) Complete initial work-up within 8 days prior to treatment that allows definite staging.
(6) Able to comply with scheduled follow-up and with management of toxicity.
(7) Signed informed consent from patients and/or their parents or legal guardians.
(8) JPLSG-CHM-14 registration.

Exclude criteria

Histology and staging disease
(1)Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study - In phase II study (PMLBL) patients with CNS involvement are not eligible.

General conditions
(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) There will be no exclusion criteria based on organ function. Dosing guidelines for organ
dysfunction are provided in annexe D1.

Prior therapy
(5) Past or current anti-cancer treatment except corticosteroids of less than 7 days duration in total.

(6) Exclusion criteria related to rituximab
6-1)Tumor cell negative for CD20 (absence of result due to technical problems in the presence of other characteristics suggestive of BL/DLBCL, including genetic and phenotypic features, is not an exclusion criteria).
6-2) Prior exposure to rituximab.
6-3) Severe active viral infection, especially hepatitis B.
6-4) Severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of registration. Contact the national co- investigator for further advice if necessary.
6-5) Hepatitis B carrier status history of HBV or positive serology. A patient is considered as HBV
carrier or to have (had) HBV infection in case of:
6-5-1) Unimmunized and HBsAg and/or anti-HBs antibody and/or anti- HBc antibody positive,
6-5-2)Immunized and HBsAG and/or anti-HBc antibody positive.

Others
(7) Participation in another investigational drug clinical trial.
(8) Patients who, for any reason, are not able to comply with the national legislation.

Related Information

• Primary Sponsor: Mori Tetsuya
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Friends of Leukemia Research Fund
• Secondary ID(s): UMIN000021286