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

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

NCT ID: NCT06257394

Condition: Acute Lymphoblastic Leukemia, Pediatric

Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Dasatinib

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Dasatinib(Sprycel) arm
Description: ▪ 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.
Arm group label: [Arm A, Dasatinib(Sprycel) Arm]

Intervention type: Drug
Intervention name: Non-Dasatinib(Sprycel) arm
Description: ▪ 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
Arm group label: [Arm B, Non-Dasatinib(Sprycel) Arm]

Summary: Very high-risk acute lymphoblastic leukemia

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 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

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 1 Year

Maximum age: 19 Years

Healthy volunteers: No

Start date: March 1, 2024

Completion date: December 31, 2030

Lead sponsor:
Agency: Hyoung Jin Kang
Agency class: Other

Source: Seoul National University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06257394