Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea (VHR ALL)
Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)
Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
- If Minimal Residual Disease & qPCR not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → DI(Delayed Intensification) #1 → IM(Interim Maintenance) #2 → DI(Delayed Intensification) #2 → Maintenance
- If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- If Minimal Residual Disease & qPCR(Quantitative Polymerase Chain Reaction) not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, HD Cytarabine
If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-reinduction : Consolidation #3 using Blinatumomab
- In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.
Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction
Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
- If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- If Minimal Residual Disease positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine
- If Minimal Residual Disease positivie after the post-reinduction : Consolidation #3 using Blinatumomab
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hyoung Jin Kang, Ph.D
- Phone Number: +82-2-2072-3452
- Email: kanghj@snu.ac.kr
Study Contact Backup
- Name: Hyoung Jin Kang
- Phone Number: +82220723452
- Email: kanghj@snu.ac.kr
Study Locations
-
-
-
Daegu, South Korea, 41404
- Recruiting
- Kyungpook National University Chilgok-Hospital
-
Contact:
- Ji Yoon Kim, Professor
- Phone Number: +82-53-200-5704
- Email: phojyk@knu.ac.kr
-
Daejeon, South Korea, 35015
- Recruiting
- Chungnam National University Hospital
-
Contact:
- Yeon Jung Lim, Professor
- Phone Number: +82-10-2705-1743
- Email: heagori@daum.net
-
Hwasun, South Korea, 58128
- Recruiting
- Chonnam National University Hwasun Hospital
-
Contact:
- Hee Jo Baek, Professor
- Phone Number: +82-61-379-8060
- Email: swan93@naver.com
-
Jeju City, South Korea, 63241
- Recruiting
- Jeju National University Hospital
-
Contact:
- Hyun Sik Kang, Professor
- Phone Number: +82-64-717-1528
- Email: medyapsb@naver.com
-
Seoul, South Korea, 05505
- Recruiting
- Asan Medical Center
-
Contact:
- Ho Joon Im, Professor
- Phone Number: 8201062311573
- Email: hojim@amc.seoul.kr
-
Seoul, South Korea, 03080
- Recruiting
- Seoul National University Hospital
-
Contact:
- Hyoung Jin Kang, Professor
- Phone Number: +82-2-2072-3452
- Email: kanghj@snu.ac.kr
-
Seoul, South Korea, 06351
- Recruiting
- Samsung Medical Center
-
Contact:
- Hee Young Ju, Professor
- Phone Number: +82-2-3410-0865
- Email: hyju320@gmail.com
-
Seoul, South Korea, 03722
- Recruiting
- Severance Hospital
-
Contact:
- Seung-min Hahn, Professor
- Phone Number: +82-2-2258-9943
- Email: bluenile88@yuhs.ac
-
Seoul, South Korea, 06591
- Recruiting
- Seoul Saint Mary's Hospital
-
Contact:
- Jae Won Yoo, Professor
- Phone Number: +82-2-2258-6763
- Email: hoiring0209@gmail.com
-
Yangsan, South Korea, 50612
- Recruiting
- Pusan National University Yangsan Hospital
-
Contact:
- Eu Jeen Yang, Professor
- Phone Number: +82-10-6478-8489
- Email: 41sirius@hanmail.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions:
- 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
- When the prognosis is judged to be poor according to NGS-MRD results among high-risk ALL patients (i) In B-ALL, the NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) after consolidation therapy is 0.01% or more, and the NGS-MRD followed during interim maintenance treatment is also 0.01% or more, (ii) In T-ALL, NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) is more than 0.01% after consolidation therapy
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: [Arm A, Dasatinib(Sprycel) Arm]
▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)
|
▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)
|
|
Experimental: [Arm B, Non-Dasatinib(Sprycel) Arm]
▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction
|
▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Event free survival
Time Frame: Up to 5 years
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurred rate
Time Frame: Up to 5 years
|
As the period from enrollment to disease progression/recurrence
|
Up to 5 years
|
|
Death rate related to infusion
Time Frame: Up to 5 years
|
The time until defined by date of drug-related mortality from the date of 1st infusion
|
Up to 5 years
|
|
Adverse Event
Time Frame: From Day 1 of the clinical trial to 28 days after last drug administration
|
From Day 1 of the clinical trial to 28 days after last drug administration
|
|
|
Overall survival
Time Frame: Up to 5 years
|
The time until defined by date of all-cause mortality from the date of 1st infusion
|
Up to 5 years
|
|
The rate of Hematopoietic stem cell transplantation
Time Frame: Up to 5 years
|
The rate of Hematopoietic stem cell transplantation after the Induction and consolidation therapy
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia
- Hemic and Lymphatic Diseases
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Tyrosine Kinase Inhibitors
- Antineoplastic Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Dasatinib
Other Study ID Numbers
- H-2401-028-1500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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