The multicenter study for purposes of detection of prognostic factor of advanced stage pediatric lymphoblastic lymphoma treated with standard chemotherapy

JRCT ID: jRCTs041180173

Registered date:29/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: lymphoblastic lymphoma stage III / IV
• Date of first enrollment: 11/12/2015
• Target sample size: 90
• Study type: Interventional
• Intervention(s): Patients under 20 years old and diagnosed as stage III / IV lymphoblastic lymphoma are enrolled in this study and are treated with one of standard chemotherapy regimen NHL-BFM95.

Outcome(s)

• Primary Outcome: The ratio of cases with 6qLOH in T-cell lymphoblastic lymphoma and hazard ratio in 3-year event free survival
• Secondary Outcome: The ratio of cases with positive minimal disseminated disease (MDD) in T or B-cell lymphoblastic lymphoma and each hazard ratio in 3-year event free survival

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: < 20age old
• Gender: Both

Include criteria

(1) diagnosis of precursor T-cell lymphoblastic lymphoma or precursor B-cell lymphoblastic lymphoma (ratio of blast in bone marrow is less than 25%)
(2) diagnosis of stage III/IV disease
(3) age under 20 year old at diagnosis
(4) registration at JPLSG CHM-14 study
(5) no history of previous anti-cancer therapy except listed below ;
a) biopsy or surgical resection
b) emergency irradiation therapy within 7days
c) prednisolone therapy within 7 days
d) VCR or DNR therapy within 7 days in order to improve severe dyspnea
(6) ECOG performance status (PS) score of 0-2, or worsening to 4 due to lymphoma
(7) sufficient hepatic and renal function satisfying the laboratory data listed below ;
a) T-Bili: within 3x of age adjusted upper-limit of normal range.
b) Creatinine: within 3x of age adjusted upper-limit of normal range.
(8) observation for at least 3 years after biginning treatment
(9) written informed consent obtained from patient or guardians.

Exclude criteria

(1) Down syndrome.
(2) Other previous illness of malignant tumor or previous therapy of organ transplantation including hematopoietc stem cells.
(3) history of congenital or acquired immunodeficiency.
(4) uncontrolled infection, including active tuberculosis infection and positive of HIV antibody.
(5) pregnancy or high possibility of pregnancy and giving suck woman.
(6) QTfc, corrected by Friderics formula as QTfc = QT/RR*1/3, is more than 0.45 seconds.
(7) CNS hemorrage more than grade 3 of CACAE v4.0
(8) MDS, Ph1 positive
(9) any inappropriate status judged by
physician.

Related Information

• Primary Sponsor: Mori Takeshi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Children's Cancer Association of Japan
• Secondary ID(s): UMIN000018780