ALL-Ph18
- Conditions
- Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- Registration Number
- JPRN-jRCTs041190067
- Lead Sponsor
- Shimada Hiroyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 57
1) Diagnosis of Ph+ALL
2) Aged 1-19 years
3) ECOG performance status (PS) score of 0-2, or worsening to 3 due to leukemia
4) Sufficient hepatic and renal function satisfying the laboratory data listed below
a) T-Bil: within 3x of age adjusted upper-limit of normal range
b) Creatinine: within 3x of age adjusted upper-limit of normal range
5) Registration of JPLSG CHM-14
6) Written informed consent obtained from guardians or both of patient and guardians
1) CNS hemorrhage grade 3 or more of CTCAE v4.03
2) Uncontrolled infection
3) Pregnancy or high possibility of pregnancy and giving suck woman
4) History of congenital or acquired immunodeficiency
5) Down syndrome
6) QTfc, corrected by Fridericia formula as QTfc = QT/RR*1/3, is 0.45 or more seconds
7) Uncontrolled diabetes mellitus
8) Liver cirrhosis
9) Severe psychiatric disorder
10) 3 weeks or more after the start of induction therapy
11) History of tyrosine kinase-combined induction therapy
12) Any inappropriate status judged by physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3 years event free survival<br>Transplantation avoidance rate in first complete remission
- Secondary Outcome Measures
Name Time Method 7 years event free survival<br>3 years overall survival<br>7 years overall survival<br>Cumulative rate of relapse<br>Cumulative rate of death during continuous complete remission<br>Rate of remission induction<br>Rate of adverse events<br>Evaluation of quality of life