Tests chemotherapy with blinatumomab and dasatinib or imatinib in new leukemia cases
Tests chemotherapy, blinatumomab and a targeted drug in newly diagnosed Philadelphia-positive leukemia.
Plain-language title generated from the registry record
Registry title: Study on chemotherapy and experimental drugs in patients with Philadelphia Chromosome positive and ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia
Key facts
- Where
- Aarhus N, Copenhagen Oe, Odense C, and Roskilde, DenmarkSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children, teenagers and young adults with newly diagnosed Ph+ or ABL-class Ph-like B-cell acute lymphoblastic leukemia. It tests chemotherapy with blinatumomab and a TKI drug.
- Age
- Older than 365 days and younger than 18 years (AIEOP-BFM sites), younger than 22 years (COG sites) or younger than 46 years (ALLTogether sites).
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed Ph+ or ABL-class Ph-like B-ALL; leukemia cells must carry CD19. Ph+ patients have had no more than 14 days of induction therapy. Ph-like patients have finished 4 or 5 weeks of induction chemotherapy.
- Earlier treatment
- Ph+ patients must have started induction therapy (vincristine, a corticosteroid, pegaspargase or calaspargase pegol). No more than 14 days of TKI for Ph+, or 35 days for Ph-like. No other TKIs besides imatinib or dasatinib.
- Biomarker or test result
- BCR::ABL1 shown by a validated test, or an ABL-class fusion involving ABL1, ABL2, CSF1R or PDGFRB.
Main reasons for not taking part
- Known chronic myeloid leukemia (CML)
- Down syndrome (trisomy 21)
- Pregnancy or breast feeding
- Leukemia that developed after earlier cancer treated with chemotherapy
- Serious central nervous system disease, or congenital long QT syndrome, ventricular arrhythmias or heart block
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- What type of cancer has the patient been diagnosed with?
- Is this cancer newly diagnosed, or has it come back or not responded to treatment?
- Is the patient pregnant or breastfeeding?
- Has the patient had Down syndrome (an extra copy of chromosome 21) diagnosed?
Where in Denmark
- Aarhus University HospitalAarhus N, DenmarkTaking people
- RigshospitaletCopenhagen Oe, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
- Zealand University HospitalRoskilde, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Universita Degli Studi Di Milano Bicocca
- Trial code
- EU 2025-520982-39-00
- Record updated
- 8 May 2026
- Original description
1. To estimate the 3-year event free survival (EFS) of children, adolescents, and young adults with newly-diagnosed Ph+ (BCR::ABL1-rearranged) B-ALL who are treated with a modified Berlin-Frankfurt-Münster (mBFM) chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous dasatinib. 2. To estimate the 3-year EFS of children, adolescents, and young adults 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 gene fusions or dasatinib for those without PDGFRB gene fusions 3. 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.Read full original descriptionShow less
AALL2131/EsPhALL2022, An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitor with Blinatumomab in Patients with Newly Diagnosed Philadelphia Chromosome Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia
1. To estimate the 3-year event free survival (EFS) of children, adolescents, and young adults with newly-diagnosed Ph+ (BCR::ABL1-rearranged) B-ALL who are treated with a modified Berlin-Frankfurt-Münster (mBFM) chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous dasatinib. 2. To estimate the 3-year EFS of children, adolescents, and young adults 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 gene fusions or dasatinib for those without PDGFRB gene fusions 3. 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.
Inclusion: 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; Adequate liver function; Adequate cardiac function; 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; 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; 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; Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vincristine; Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy; 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; 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; Adequate renal function.
Exclusion: 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; Known history of chronic myeloid leukemia (CML); 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; ALL developing after a previous cancer treated with cytotoxic chemotherapy; Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation; Down syndrome (trisomy 21); Pregnancy and breast feeding; Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib; Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block; Patients with known Charcot-Marie-Tooth disease; ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase.