Phase.1: Baseline characteristics and laboratory findings,
Conditions
Interventions
IT MTX group were treated with age-
adjusted IT MTX (1yr ≤ age < 2yr: 8mg
2yr ≤ age < 3yr: 10mg
and age ≥3yr: 12mg) ,TIT group were received TIT as (1yr ≤ age < 2yr: MTX 10mg,
cytarabine 20 mg,
and hydrocortisone 10 mg
2yr ≤ age < 3yr: MTX 12mg ,
cytarabine 25 mg,
and hydrocortisone 12 mg
age ≥3yrs: MTX 15mg,
cytarabine 30 mg,
and hydrocortisone 15 mg).
Experimental Drug,Experimental Drug
intrathecal methotrexate ,triple intrathecal therapy
Sponsors
Isfahan university of medical sciences
Isfahan university of medical sciences
Eligibility
Sex/Gender
All
Age
1 Years to 10 Years
Inclusion criteria
Inclusion criteria:  Age between 1-10 years at diagnosis,  A confirmed diagnosis of ALL,  White blood cell (WBC) count below 50×109/L at the time of diagnosis,  Absence of high-risk cytogenetic abnormalities including t(4;11), t(1;19), t(9;22), MLL gene rearrangements at chromosome band 11q23, and hypodiploidy (≤45 chromosome) (13), and  Cessation of treatment at least one year before the study.
Exclusion criteria
Exclusion criteria:  Having a history of developmental delay, L3 morphology, T-cell phenotype,  CNS or testicular involvement at the time of diagnosis,  Induction failure, and  History of CRT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| isolated CNS relapses (i-CNS) and five-year survival of the two groups was compared < 18 months or ≥18 months after the first complete remission, 5 year lymphoblast in CSF centrifuge preparation,patients who were alive for five years after the beginning | — |
Secondary
| Measure | Time frame |
|---|---|
| Intelligence Quotient - Wechsler Intelligence Scale for Children- Fourth Edition (WISC-IV) | — |
Countries
iran
Contacts
Public ContactNahid Reisi
Department of Pediatric Hematology and Oncology, Faculty of Medicine, Child Growth and Development R
Outcome results
None listed