blinatumomab for Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia|ABL-class Ph-like B-cell acute lymphoblastic leukemia

Inclusion criteria

• {"criterion_text":"- Patients must be >365 days and <18 years (for AIEOP-BFM), >365 days and <22 years (for COG) and >365 days and <46 years (for ALLTogether sites) at the time of enrollment."}
• {"criterion_text":"- Adequate liver function"}
• {"criterion_text":"- Adequate cardiac function"}
• {"criterion_text":"- Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB."}
• {"criterion_text":"- Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on Day 15 from the first dose of vincristine during Induction therapy."}
• {"criterion_text":"- Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vincristine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and/or other standard cytotoxic chemotherapy."}
• {"criterion_text":"- Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vincristine."}
• {"criterion_text":"- Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy"}
• {"criterion_text":"- Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL."}
• {"criterion_text":"- Patients must have a performance status corresponding to ECOG scores of ≤2 or Karnofsky and Lansky performance scores ≥50%. Use Karnofsky for patients >16 years of age and Lansky for patients ≤ 16 years of age."}
• {"criterion_text":"- Adequate renal function"}

Exclusion criteria

• {"criterion_text":"- Known history of chronic myeloid leukemia (CML)"}
• {"criterion_text":"- Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement"}
• {"criterion_text":"- HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment"}
• {"criterion_text":"- ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase."}
• {"criterion_text":"- 3.\tALL developing after a previous cancer treated with cytotoxic chemotherapy"}
• {"criterion_text":"- Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation"}
• {"criterion_text":"- Down syndrome (trisomy 21)"}
• {"criterion_text":"- Pregnancy and breast feeding"}
• {"criterion_text":"- Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib"}
• {"criterion_text":"- Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block"}
• {"criterion_text":"- Patients with known Charcot-Marie-Tooth disease"}

Primary endpoints

• {"endpoint_text":"- To estimate the 3-year event free survival (EFS) of children, adolescents, and young adults <25 years old with newly-diagnosed Ph+ B-ALL who are treated with a modified Berlin-Frankfurt-Münster (BFM) chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous dasatinib","definition_or_measurement_approach":"Estimate 3-year event-free survival (EFS) in the specified population treated with the specified regimen (time-to-event analysis assessing events over 3 years)."}
• {"endpoint_text":"- To estimate the 3-year EFS of children, adolescents, and young adults <25 years old with newly-diagnosed ABL-class Ph-like B-ALL who are treated with a modified BFM chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous imatinib for those with PDGFRB fusions or dasatinib for those without PDGFRB fusions","definition_or_measurement_approach":"Estimate 3-year event-free survival (EFS) in the ABL-class Ph-like cohort, with subgroup assignment based on PDGFRB fusion status; measured as time-to-event over 3 years."}
• {"endpoint_text":"- To describe the safety and toxicity profile (infections, mucositis, neurotoxicity, cytokine release syndrome, hypogammaglobulinemia, therapy delays > 14 days, and treatment-related mortality) for patients with Ph+ or ABL-class Ph-like B-ALL treated on this novel chemo-immunotherapy backbone with continuous TKI.","definition_or_measurement_approach":"Descriptive safety endpoints capturing incidences of listed toxicities, therapy delays >14 days, and treatment-related mortality; standard toxicity grading and summarisation over treatment period."}

Secondary endpoints

• {"endpoint_text":"- To estimate the 3-year overall survival (OS) of patients with Ph+ and ABL-class Ph-like B-ALL, respectively.","definition_or_measurement_approach":"Estimate 3-year overall survival (OS) by Kaplan-Meier/time-to-event analysis for each cohort."}
• {"endpoint_text":"- To estimate the 3-year EFS, disease-free survival (DFS), cumulative incidence rates (CIR) of relapse, and treatment related mortality (TRM), and OS of patients with ABL-class Ph-like B-ALL stratified by their underlying ABL-class fusion subtypes.","definition_or_measurement_approach":"Estimate 3-year EFS, DFS, CIR of relapse, TRM and OS overall and stratified by ABL-class fusion subtype (time-to-event analyses and cumulative incidence methods)."}
• {"endpoint_text":"- To describe rates of EOC/TP2 MRD negativity defined as <1x10-4 or <0.01% for patients with ABL-class Ph-like B-ALL collectively and based on their ABL-class fusion subtypes.","definition_or_measurement_approach":"Proportion of patients achieving minimal residual disease (MRD) negativity at end of consolidation (EOC)/timepoint 2 (TP2), defined as <1x10^-4 (<0.01%), reported overall and by fusion subtype."}

Austria

Earliest CTIS Part Ii Submission Date

07-11-2025

Latest Decision Or Authorization Date

14-12-2025

Processing Time Days

37

Number Of Participants

3

Germany

Earliest CTIS Part Ii Submission Date

07-11-2025

Latest Decision Or Authorization Date

11-12-2025

Processing Time Days

34

Number Of Participants

20

Denmark

Earliest CTIS Part Ii Submission Date

24-11-2025

Latest Decision Or Authorization Date

10-12-2025

Processing Time Days

16

Number Of Participants

3

France

Earliest CTIS Part Ii Submission Date

11-11-2025

Latest Decision Or Authorization Date

15-12-2025

Processing Time Days

34

Number Of Participants

19

Hungary

Earliest CTIS Part Ii Submission Date

14-10-2025

Latest Decision Or Authorization Date

15-12-2025

Processing Time Days

62

Number Of Participants

2

Lithuania

Earliest CTIS Part Ii Submission Date

18-11-2025

Latest Decision Or Authorization Date

10-12-2025

Processing Time Days

22

Number Of Participants

1

Spain

Earliest CTIS Part Ii Submission Date

01-10-2025

Latest Decision Or Authorization Date

12-12-2025

Processing Time Days

72

Number Of Participants

5

Norway

Earliest CTIS Part Ii Submission Date

25-11-2025

Latest Decision Or Authorization Date

11-12-2025

Processing Time Days

16

Number Of Participants

2

Slovakia

Earliest CTIS Part Ii Submission Date

31-10-2025

Latest Decision Or Authorization Date

11-12-2025

Processing Time Days

41

Number Of Participants

2

Italy

Earliest CTIS Part Ii Submission Date

21-11-2025

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

18

Number Of Participants

20

Netherlands

Earliest CTIS Part Ii Submission Date

10-11-2025

Latest Decision Or Authorization Date

11-12-2025

Processing Time Days

31

Number Of Participants

5

Finland

Earliest CTIS Part Ii Submission Date

06-11-2025

Latest Decision Or Authorization Date

13-02-2026

Processing Time Days

99

Number Of Participants

2

Czechia

Earliest CTIS Part Ii Submission Date

25-09-2025

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

225

Number Of Participants

3

Primary sponsor

Full Name

Universita Degli Studi Di Milano Bicocca

Organisation Type

Educational Institution

Country Of Registered Address

Italy

Third parties

• {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"5","organisation_type":"Hospital/Clinic/Other health care facility"}