Adding Asciminib to Usual Treatment for Adults With Newly Diagnosed Philadelphia Chromosome Posit… (NCT06773936) | Clinical Trial Compass
By InvitationPhase 2
Adding Asciminib to Usual Treatment for Adults With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia
United States55 participantsStarted 2026-05-15
Plain-language summary
This phase II trial is to answer the question of "can adding the study drug, asciminib to usual treatment improve how chemotherapy works against Ph+ Acute Lymphoblastic Leukemia (ALL) and is this approach better than the usual approach for Ph+ALL?"
Who can participate
Age range60 Years
SexALL
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Inclusion Criteria:
* Participants must have a new diagnosis of Philadelphia chromosome positive (Ph+) ALL by cytogenetics, FISH, or polymerase chain reaction (PCR). Diagnostic specimens must be submitted to the site's local CLIA-approved cytogenetics laboratory and results (cytogenetics, FISH, or PCR) must confirm Ph status prior to registration.
* Participants must have BCR-ABL status (p190 or p210) performed but results don't need to be back prior to Step 1 registration.
* Participants must have evidence of CD19+ ALL in their marrow or peripheral blood with at least 20% lymphoblasts present in blood or bone marrow collected within 28 days prior to registration. Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage. Appropriate marker studies including CD19 (B cell) must be performed. If a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate Immunohistochemistry (IHC) testing, including CD19, must be performed on the bone marrow biopsy to determine lineage. Participants with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible. CD19+ is defined as \> 20% expression by flow cytometry or IHC.
* Participants must have recovered from any prior major surgery adverse effects within 14 days prior to registration, to the satisfaction of the local investigator.
* Participants must be ≥ 60 years old, or, if participants are under 60 years of age, they are not suitable for s…
What they're measuring
1
Major molecular remission by polymerase chain reaction for BCR-ABL