ALL-B12
- Conditions
- B cell precursor Acute Lymphoblastic Leukemia
- Registration Number
- JPRN-jRCTs041180101
- Lead Sponsor
- Koh Katsuyoshi
- Brief Summary
A nationwide multicenter clinical trial conducted at a large number of hospitals showed excellent results. The lower NRM rate can be mainly attributed to the higher proportion of SR group due to the use of NCI criteria as a stratification factor and the limited number of patients eligible for allo-HSCT due to the intensified early consolidation. Prophylactic cranial irradiation was also successfully eliminated. On the other hand, high survival rates were achieved with appropriate intensification.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1936
1) diagnosis of B cell precursor ALL
2) age between 1 and 19 years old
3) ECOG performance status (PS) score of 0-2 .However, PS scores up to 3 are permitted when the deterioration of PS is thought to be due to leukemia.
4) no history of previous chemotherapy or radiation therapy
5) sufficient hepatic and renal function satisfying the laboratory data listed below ;
(1)T-Bili: within 3x of age adjusted upper-limit of normal range.
(2)Creatinine: within 3x of age adjusted upper-limit of normal range.
6) written informed consent obtained from
patient or guardians.
1) mature B-ALL
2) Ph positive ALL
3) True Mixed Lineage Leukemia
4) CNS hemorrage more than grade 3 of CTCAE v4.0
5) uncontrolled infection, including active tuberculosis and positive of HIV antibody.
6) pregnancy or high possibility of pregnancy and giving suck wiman.
7) history of congenital or acquired immunodeficiency.
8) QTfc, corrected by Fridericia formula as
QTfc = QT/RR*1/3, is more than 0.45 seconds.
9) any inappropriate status judged by
physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Five years event free survival of each risk group
- Secondary Outcome Measures
Name Time Method 1) Five years event free survival, overall survival, and CNS relapse rate of whole group <br>2) Five years overall survival and CNS relapse rate of each risk group <br>3) Complete remission rate after induction (IA) and after early intensification (IB) of each risk group and whole group <br>4) Incidence of adverse events <br>5) Success rate of MRD estimation at time point 1 and time point 2. Correlation between MRD level and event free survival, overall survival <br>6) Estimation of quality of life (QOL) by Questionnaire survey to patients and families <br>7) Exploratory estimation of correlation between biological abnormality and prognosis