A PHASE II, MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ASCIMINIB IN PEDIATRIC PARTICIPANTS NEWLY DIAGNOSED OR PREVIOUSLY TREATED WITH PHILADELPHIA POSITIVE CHRONIC MYELOGENOUS LEUKEMIA IN CHRONIC PHASE (PH+ CML-CP) WITH OR WITHOUT KNOWN T315I MUTATION

Registry ID

CABL001I12202

Source registry

HEALTH_CANADA

Status

Ongoing

Phase

PHASE2

Study type

INTERVENTIONAL

Sponsor

NOVARTIS PHARMACEUTICALS CANADA INC

Start date

2026-04-30

Last update

2026-02-27

Conditions

• CHRONIC MYELOGENOUS LEUKEMIA (CML)

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• ASCIMINIB, WITH OR WITHOUT DASATINIB COMBINATION, AS A 2ND-LINE THERAPY TO ADVANCE THE TREATMENT FOR CHRONIC MYELOGENOUS LEUKEMIA IN CHRONIC PHASE (ASC2ADVANCE)
• A PHASE III, MULTI-CENTER, OPEN-LABEL, RANDOMIZED STUDY OF ORAL ASCIMINIB VERSUS INVESTIGATOR SELECTED TKI IN PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA IN CHRONIC PHASE
• AN OPEN LABEL, MULTI-CENTER ASCIMINIB ROLL-OVER STUDY TO ASSESS LONG-TERM SAFETY IN PATIENTS WHO HAVE COMPLETED A NOVARTIS SPONSORED ASCIMINIB STUDY AND ARE JUDGED BY THE INVESTIGATOR TO BENEFIT FROM CONTINUED TREATMENT
• PHASE 3 RANDOMIZED, CONTROLLED STUDY OF BLINATUMOMAB ALTERNATING WITH LOW-INTENSITY CHEMOTHERAPY VERSUS STANDARD OF CARE FOR OLDER ADULTS WITH NEWLY DIAGNOSED PHILADELPHIA NEGATIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA WITH SAFETY RUN-IN (GOLDEN GATE STUDY)

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