SYF1997a27528504689b2c61ab5d6d7cad8Registry ID: 2025-522019-40-00|
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A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)
Secondary identifiers
interventional
N/A
16 countries
25
The primary objective for Part 1 dose escalation is to determine the RP2D and the primary endpoints will be the incidence of DLTs and incidence and severity of AEs and laboratory safety findings during cycle 1. The primary objective for Part 2 dose expansion will be to assess complete remission rates at the end of cycle 1 and the primary endpoint will be proportion of CR evaluable Ph+ participants achieving CR at the end of cycle 1
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 18, 2025
Actual (reported)Part 1 Dose Escalation: Incidence of DLTs occurring during cycle 1 (debulking induction)
Part 1 Dose Escalation: incidence and severity of AEs and laboratory safety findings during cycle 1 (debulking induction)
Part 2 Dose Expansion: Proportion of CR evaluable participants who achieve CR treated at the RP2D at the end of cycle 1 (debulking induction)
• Proportion of participants who had a CR at the end of cycle 2 and cycle 3
• Proportion of participants who had CR and/or CRi at and by the end of: cycle 1, cycle 2, and cycle 3
• Proportion of participants who have NGS MRD negative CR at and by the end of: end of cycle 1, cycle 2, and cycle 3.
• Proportion of participants who have a MFC MRD negative CR at and by the end of: cycle 1, cycle 2, and cycle 3.
• Proportion of participants who have a NGS and/or MFC MRD negative CR and/or CRi at and by the end of: cycle 1, cycle 2, and cycle 3
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
BLINATUMOMAB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
DEXAMETHASONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
HYDROCORTISONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
METHOTREXATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
CYTARABINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
BLINATUMOMAB
Named ingredient: blinatumomab
View registry recordDEXAMETHASONE
Named ingredient: Dexamethasone
View registry recordHYDROCORTISONE
Named ingredient: Hydrocortisone
View registry recordMETHOTREXATE
Named ingredient: Methotrexate
View registry recordCYTARABINE
Named ingredient: Cytarabine
View registry recordDBL methotrexate injection
Named ingredient: Methotrexate
View registry recordASCIMINIB HYDROCHLORIDE
Named ingredient: Asciminib hydrochloride
View registry recordHospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, 08950, Spain
Hospital Universitari Vall D Hebron
Barcelona, 08035, Spain
Hospital Infantil Universitario Nino Jesus
Madrid, 28009, Spain
Novartis Pharma Arzneimittel GmbH
First Submitted
December 18, 2025
Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
SOLUTION FOR INJECTION
Formulated product
DBL methotrexate injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
ASCIMINIB HYDROCHLORIDE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
VINCRISTINE SULFATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordVINCRISTINE SULFATE
Named ingredient: Vincristine sulfate
View registry recordContact the study team to confirm eligibility.
Hospital Universitario La Paz
Madrid, 28046, Spain
Prinses Maxima Centrum voor Kinderoncologie B.V.
Utrecht, 3584 CS, Netherlands
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, 33000, France
Hopital Saint Louis
Paris, 75010, France
Hospital Hotel Dieu
Nantes, 44000, France
Centre Hospitalier Universitaire De Bordeaux
Pessac, 33600, France
Robert Debre University Hospital
Paris, 75019, France
Hospices Civils De Lyon
Lyon, 69008, France
Centre Hospitalier Universitaire De Rennes
Rennes Cedex 9, 35033, France
Centre Hospitalier Regional De Marseille
Marseille, 13005, France
Institute Of Hematology And Blood Transfusion
Prague, 128 00, Czechia
Fakultni Nemocnice Motol A Homolka
Prague, 150 00, Czechia
Universitaetsklinikum Essen AöR
Essen, 45147, Germany
Charite Universitaetsmedizin Berlin KöR
Berlin, 13353, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Universitaetsklinikum Erlangen AöR
Erlangen, 91054, Germany
Universitaetsklinikum Koeln AöR
Cologne, 50937, Germany
Goethe University Frankfurt
Frankfurt Am Main, 60590, Germany
Rigshospitalet
Copenhagen Oe, 2100, Denmark
IRCCS Istituto Giannina Gaslini
Genoa, 16147, Italy
Fondazione IRCCS San Gerardo Dei Tintori
Monza, 20900, Italy
Ospedale Pediatrico Bambino Gesu
Rome, 00165, Italy