ASCIMINIB HYDROCHLORIDE for Acute lymphoblastic leukemia (BCR-ABL1-positive, Ph+) | Acute lymphoblastic leukemia (BCR-ABL1-like, ABL-class)

Inclusion criteria

• {"criterion_text":"-Male or female participants ≥1 year to ≤30 years of age at screening"}
• {"criterion_text":"-Participants with documented history of either Ph+ ALL or ABL-class Ph-like ALL with ABL1 or ABL2 rearrangements. Genetic testing will be performed locally and eligible alterations confirmed by treating investigators; central confirmation will not be performed as part of the study. (Of note, participants with T315I mutations are eligible for inclusion in Part 1 and Part 2)."}
• {"criterion_text":"-Active B-Cell ALL at screening defined by MFC or IG/TCR PCR of ALL blasts >0.01% in participants with either: a. Primary refractory disease (>0.01% ALL blasts present at the end of consolidation) OR b. Relapsed ALL with evidence of involvement of BM with ALL (MFC or IG/TCR PCR>0.01%) after at least one line of therapy"}
• {"criterion_text":"-Participants with CNS1, CNS2, CNS3a or CNS3b at screening."}
• {"criterion_text":"-Documented history of CD19 expressing B-cell ALL (in peripheral blood or bone marrow by flow cytometry) a.\tFor participants who received anti-CD19 targeted therapy (e.g CD19 CAR T cells or blinatumomab), CD19 expressing B-cell ALL must be documented after anti-CD19 therapy completion prior to cycle 1 day 1."}

Exclusion criteria

• {"criterion_text":"-Participants with >3 relapses of ALL at screening."}
• {"criterion_text":"-Extramedullary disease (non-CNS and/ or isolated CNS disease) at screening"}
• {"criterion_text":"-Participants with CNS3c at screening (Clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome)."}
• {"criterion_text":"-History of hematopoietic stem cell transplant within the prior 12 weeks"}
• {"criterion_text":"-Presence of active acute or chronic graft-versus-host disease (GVHD). Hematopoietic stem cell transplant recipients receiving any agent to treat or prevent GVHD within 4 weeks are not eligible for this trial."}

Primary endpoints

• {"endpoint_text":"-Part 1 Dose Escalation: Incidence of DLTs occurring during cycle 1 (debulking induction)","definition_or_measurement_approach":"Incidence (proportion) of dose-limiting toxicities (DLTs) observed during cycle 1 (debulking induction) in Part 1 dose escalation."}
• {"endpoint_text":"-Part 1 Dose Escalation: incidence of severity of AEs and laboratory safety findings","definition_or_measurement_approach":"Incidence and severity grading of adverse events (AEs) and laboratory safety abnormalities during Part 1 assessed using standard safety reporting and laboratory evaluations."}
• {"endpoint_text":"-Part 2 Dose Expansion: Proportion of CR evaluable participants who achieve CR treated at the RP2D at the end of cycle 1 (debulking induction)","definition_or_measurement_approach":"Proportion of participants evaluable for complete remission (CR) who achieve CR at the end of cycle 1 when treated at the recommended phase 2 dose (RP2D)."}

Secondary endpoints

• {"endpoint_text":"-• Proportion of participants who had a CR at the end of cycle 2 and cycle 3","definition_or_measurement_approach":"Proportion of participants achieving CR assessed at end of cycle 2 and end of cycle 3."}
• {"endpoint_text":"-• Proportion of participants who had CR and/or CRi at and by the end of: cycle 1, cycle 2, and cycle 3","definition_or_measurement_approach":"Proportion of participants with CR and/or CRi assessed at and by the end of cycles 1, 2 and 3."}
• {"endpoint_text":"-• Next generation sequencing MRD negative rate at and by the end of: end of cycle 1, cycle 2, and cycle 3.","definition_or_measurement_approach":"MRD negativity rate measured by next generation sequencing (NGS) at and by the end of cycles 1, 2 and 3."}
• {"endpoint_text":"-• MFC MRD negative CR/CRi rate at and by the end of: cycle 1, cycle 2, and cycle 3.","definition_or_measurement_approach":"MRD negativity rate measured by multiparameter flow cytometry (MFC) in participants achieving CR/CRi at and by the end of cycles 1, 2 and 3."}
• {"endpoint_text":"-• Disease Free Survival","definition_or_measurement_approach":"Disease-free survival measured from a defined starting point (per protocol) to relapse or death; specific censoring and calculation method per protocol."}
• {"endpoint_text":"-• Overall survival","definition_or_measurement_approach":"Overall survival measured from a defined starting point (per protocol) to death from any cause."}
• {"endpoint_text":"-Type, frequency, severity of treatment emergent adverse events, changes in laboratory parameters, ECG, and other safety data.","definition_or_measurement_approach":"Safety endpoints include incidence, frequency and severity (grading) of treatment-emergent AEs, laboratory parameter changes, ECG findings and other safety assessments as recorded during the study."}
• {"endpoint_text":"-PK parameters of asciminib at steady state: AUClast, Cmax, Tmax, Ctrough over time (sparse PK sampling)","definition_or_measurement_approach":"Pharmacokinetic parameters of asciminib at steady state (AUClast, Cmax, Tmax, Ctrough) assessed via sparse PK sampling per protocol schedule."}

Methods

• Recruitment arrangements submitted as K1 documents for multiple countries (country-specific K1 recruitment arrangements).
• Advertisements submitted as K2 documents (country-specific advertisements) — K2 advertisement documents are present for Denmark, France, Germany, Italy, Spain, Netherlands and other submitted countries. Target audience in documentation: participants/patients with relapsed or refractory Ph+ or ABL-class Ph-like ALL.

Czechia

Earliest CTIS Part Ii Submission Date

19-03-2026

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

40

Number Of Sites

2

Number Of Participants

2

Denmark

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

27

Number Of Sites

1

Number Of Participants

2

France

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

28

Number Of Sites

8

Number Of Participants

5

Germany

Earliest CTIS Part Ii Submission Date

30-03-2026

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

31

Number Of Sites

6

Number Of Participants

3

Italy

Earliest CTIS Part Ii Submission Date

24-03-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

36

Number Of Sites

3

Number Of Participants

3

Spain

Earliest CTIS Part Ii Submission Date

26-03-2026

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

39

Number Of Sites

4

Number Of Participants

4

Netherlands

Earliest CTIS Part Ii Submission Date

14-04-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

15

Number Of Sites

1

Number Of Participants

2

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

IQVIA Limited

Responsibilities

Central ECG Reading; general clinical trial services (sponsor contact: eu_clinical_trials_information@iqvia.com); sponsor duties include code:1 for some entries

Name

Parexel International (IRL) Limited

Responsibilities

Clinical trial services (sponsor duties code:12)

Name

Icon Clinical Research Limited

Responsibilities

Clinical trial services (sponsor duties code:1 and code:4 across entries)

Name

Labcorp Central Laboratory Services SARL

Responsibilities

Lab kits supply and sample management

Name

Scout Clinical

Responsibilities

Patient travel and accommodation reimbursement and/or arrangement

Third parties

• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel and accommodation reimbursement and/or arrangement","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Central ECG Reading; code:3","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Lab kits supply and sample management","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:6","organisation_type":"Non-Pharmaceutical company"}
• {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Mipharm S.p.A.","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Patient Guides and Tools","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Australia","full_name":"Sa Pathology","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}