Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-19
SponsorHyoung Jin Kang
About this trial
Very high-risk acute lymphoblastic leukemia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Philadelphia chromosome-positive t(9;22)(q34;q11) or
Patients with failed remission who had blast > 5% on bone marrow test after initial remission induction therapy or
Hypodiploidy (Number of chromosomes < 44 (less than 44)) or
E2A-HLF(Hepatic Leukemia Factor) translocation-positive or
Disqualifiers
Participants with contraindications to medications
When the study participant or their legal representative withdraws consent
Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period)
Participants who are medically unsuitable to participate in this study at the discretion of the investigator Participants participating in other interventional studies other than this protocol
Trial design
Design model
Parallel
Treatments tested in this trial
Dasatinib(Sprycel) arm
Drug▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.) * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance 2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine 2. If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab * In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.
Non-Dasatinib(Sprycel) arm
Drug▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT 2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3‡ → Allogeneic HSCT 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine 2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: [Arm A, Dasatinib(Sprycel) Arm]Experimental treatment 1 intervention
Group B: [Arm B, Non-Dasatinib(Sprycel) Arm]Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Event free survival
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 years4
Adverse Event
Time frame
From Day 1 of the clinical trial to 28 days after last drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hyoung Jin Kang
Lead sponsor
Seoul National University Hospital
Sponsor institution
Asan Medical Center
Collaborator
Samsung Medical Center
Collaborator
Severance Hospital
Collaborator
Pusan National University Yangsan Hospital
Collaborator
Seoul St. Mary's Hospital
Collaborator
Chonnam National University Hospital
Collaborator
Chungnam National University Hospital
Collaborator
Kyungpook National University Chilgok Hospital
Collaborator
Jeju National University Hospital
Collaborator
Source ClinicalTrials.gov