B-cell Childhood Acute Lymphoblastic Leukemia, Childhood Acute Lymphoblastic Leukemia, Philadelphia Chromosome, Ph^1^, Absent
Conditions
Keywords
high risk, Philadelphia Chromosome absent, Childhood acute lymphoblastic leukemia
Brief summary
The cure rate for childhood acute lymphoblastic leukemia (ALL) has increased significantly in recent decades and expected cure rates now exceed 85%. In recent years, Tyrosine Kinase Inhibitor(TKI) has improved outcome of Philadelphia chromosome positive (Ph+)ALL . But in some high risk groups, The prognosis of patients is still very bad and the relapse rate is high. Clearly, new therapies are urgently needed to prevent and /or treat relapsed ALL.
Detailed description
1. The prognosis of childhood acute lymphoblastic leukemia(ALL) has been increased. 2. Tyrosine Kinase Inhibitor(TKI) has improved Philadelphia chromosome positive (Ph+)ALL treatment outcome. 3. The prognosis of high-risk childhood ALL except for Philadelphia chromosome positive (Ph+)ALL is very bad.
Interventions
DRUGIdarubicin(IDA)
6mg/M2 IV(in the vein) on day 16,22,29 of induction therapy, until progression or unacceptable toxicity develops.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
Children with high-risk ALL Children lower than 18years old
Exclusion criteria
Bcr/Abl(+) Children with middle-risk or standard-risk ALL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The event free survival of high risk ALL | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| The relapsed rate, death, overall survival | 2 years |
Other
| Measure | Time frame |
|---|---|
| infection rate | 2 years |
Countries
China
Contacts
Primary ContactXiaofan Zhu, MD
Outcome results
None listed