Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Conditions
Interventions
Standard Risk (SR)
Criteria: Ig/TCR MRD less than 5x10^-4 after IB
Treatment: Hematological remission-induction therapy (DP), Molecular remission-induction therapy (IA', IB), Consolidation therapy (
Sponsors
Koh Katsuyoshi
Shimada Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 years event free survival Transplantation avoidance rate in first complete remission | — |
Secondary
| Measure | Time frame |
|---|---|
| 7 years event free survival 3 years overall survival 7 years overall survival Cumulative rate of relapse Cumulative rate of death during continuous complete remission Rate of remission induction Rate of adverse events Evaluation of quality of life | — |
Contacts
Public ContactAtsushi Sato
MIYAGI CHILDREN'S HOSPITAL
Outcome results
None listed