Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea

Acute Lymphoblastic Leukemia, Pediatric Clinical Trial

— VHR ALL  

Official title:

Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06257394
• Other study ID #: H-2401-028-1500
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2024
• Source: Seoul National University Hospital
• Contact: Hyoung Jin Kang, Ph.D
• Phone: +82-2-2072-3452
• Email: kanghj[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Very high-risk acute lymphoblastic leukemia

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

1. 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

2. 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)

1. If Minimal Residual Disease & qPCR(Quantitative Polymerase Chain Reaction) not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, HD Cytarabine

2. 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

1. 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)

2. 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)

1. If Minimal Residual Disease not detected after the post-consolidation #1 :

Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine

2. If Minimal Residual Disease positivie after the post-reinduction :

Consolidation #3 using Blinatumomab

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, Pediatric
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Dasatinib(Sprycel) arm
? 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 If MRD & qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine ? DI #1 ? IM #2 ? DI #2 ? Maintenance 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 If MRD & qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine 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
? Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction Morphologic CR after the Induction : Consolidation #1 ? Consolidation #2 ? Consolidation #3 If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine ? Allogeneic HSCT 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 If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hyoung Jin Kang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival		Up to 5 years
Secondary	Overall survival	The time until defined by date of all-cause mortality from the date of 1st infusion	Up to 5 years
Secondary	Recurred rate	As the period from enrollment to disease progression/recurrence	Up to 5 years
Secondary	Death rate related to infusion	The time until defined by date of drug-related mortality from the date of 1st infusion	Up to 5 years
Secondary	Adverse Event		From Day 1 of the clinical trial to 28 days after last drug administration
Secondary	The rate of Hematopoietic stem cell transplantation	The rate of Hematopoietic stem cell transplantation after the Induction and consolidation therapy	Up to 5 years