Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-19
SponsorJae Wook Lee
About this trial
* Clinical and genetic factors consistent with High risk : Induction → Consolidation
1. BM MRD \< 0.01% : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation
<!-- -->
1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification
1. BM MRD \< 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen
* Difference in the number of \'interim maintenance(IM)\' and \'delayed intensification(DI)\' is important for chemotherapies based on MRD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 1year~19years of age at diagnosis
Patients who are newly diagnosed Pre-B ALL and meet one of the following criteria
High-risk group according to the National Cancer Institute (NCI)/Rome: Age greater than or equal to 10 years and less than 19 years at diagnosis, or white blood cell count greater than or equal to 50 x 10^9/L at diagnosis
If extra-bone marrow lesions are identified at the time of diagnosis, Central nervous system involvement (CNS3) or testicular involvement
Disqualifiers
Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
Patients with Down syndrome
potential of pregnancy or during pregnancy (patients of childbearing age need adequate contraception for the duration of the trial)
Patients who have already received steroid treatment for newly diagnosed ALL specified in the above selection criteria or chemotherapies more than one intrathecal cytarabine treatment
Trial design
Design model
Single group
Treatments tested in this trial
ALL, High risk
DrugIntervention Description : * Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% after Induction, \< 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD \< 0.01% after IM #1 : Continue with \'No. 2\' of High risk regimen starting with DI #1 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen * T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported.
Treatment groups
370 Participants
are divided into 1 treatment groupGroup A: ALL, High risk with DI #2(Doxorubicin)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Event Free Survival
Event-free survival rate for 5 years from the date of registration
Time frame
Up to 5 yearsSecondary outcomes
1
Overall Survival
The time until defined by date of all-cause mortality from the date of 1st infusion
Time frame
Up to 5 years2
Recurred rate
As the period from enrollment to disease progression/recurrence
Time frame
Up to 5 years3
Death rate related to infusion
The time until defined by date of drug-related mortality from the date of 1st infusion
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jae Wook Lee
Lead sponsor
Seoul St. Mary's Hospital
Sponsor institution
Samsung Medical Center
Collaborator
Asan Medical Center
Collaborator
Seoul National University Hospital
Collaborator
Severance Hospital
Collaborator
Pusan National University Yangsan Hospital
Collaborator
Korea University Anam Hospital
Collaborator
Ajou University School of Medicine
Collaborator
Inha University Hospital
Collaborator
Source ClinicalTrials.gov