Adding Asciminib to Usual Treatment for Adults With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia

Part of paid clinical trials in Orange, California.

Sponsor
SWOG Cancer Research Network
Study ID
NCT06773936
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • CD19+ Acute Leukemia
  • Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Induction Phase — DRUG
    Asciminib, Dasatinib, Prednisone, and Methotrexate
  • Re-Induction Phase — DRUG
    Blinatumomab, Dasatinib, Methotrexate, and Dexamethasone
  • Post-Remission — DRUG
    Blinatumomab, Dasatinib, Methotrexate and Dexamethasone
  • Maintenance — DRUG
    Asciminib, Dasatinib, Prednisone, and Methotrexate

Study Details

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?"

Key Dates

Start date
May 15, 2026
Status verified
May 2026
Primary completion
May 31, 2029
Completion
Jul 31, 2033

Study Design

Enrollment
55 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Primary Outcome Measure

Major molecular remission by polymerase chain reaction for BCR-ABL [ Time Frame: Up to 100 days after treatment start ]

Locations (8)

FacilityCityStateZIPSite coordinators
UC Irvine Medical CenterOrangeCalifornia92868-
Northwell Health/Center for Advanced MedicineLake SuccessNew York11042-
University of Rochester Medical CenterRochesterNew York14642-
Duke University Medical CenterDurhamNorth Carolina27710-
University of Cincinnati Cancer Ctr-UC Medical CtrCincinnatiOhio45267-
Cleveland Clinic FoundationClevelandOhio44195-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Baptist Memorial Health CareMemphisTennessee38120-

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