ALL-Ph18

JRCT ID: jRCTs041190067

Registered date:18/09/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
• Date of first enrollment: 28/10/2019
• Target sample size: 57
• Study type: Interventional

Intervention(s)

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 (HR1, HR2, HR3),
(1) Chimeric MRD less than 0.01% after HR3:
Re-induction therapy (IIIA', IIIB), Interim maintenance therapy (IM), IIIA', IIIB, IM, IIA', IIIB, Maintenance therapy
(2) Chimeric MRD 0.01% or more after HR3:
Allogeneic hematological cell transplantation

High Risk (HR)
Criteria: Ig/TCR MRD 5x10^-4 or more after IB
Treatment: Hematological remission-induction therapy (DP), Molecular remission-induction therapy (IA', IB), Consolidation therapy (HR1, HR2, HR3), Allogeneic hematological cell transplantation

Outcome(s)

Primary Outcome

3 years event free survival
Transplantation avoidance rate in first complete remission

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: <= 19age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Shimada Hiroyuki
• Secondary Sponsor: Kodama Yuichi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development