A Phase II Trial of Asciminib, Dasatinib, Prednisone, and Blinatumomab for Participants With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia

NCT06773936 Phase 2 ENROLLING_BY_INVITATION

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?"

Details

Lead sponsor	SWOG Cancer Research Network
Phase	Phase 2
Status	ENROLLING_BY_INVITATION
Enrolment	55
Start date	2026-05-15
Completion	2033-07

Conditions

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

Interventions

• Induction Phase
• Re-Induction Phase
• Post-Remission
• Maintenance

Primary outcomes

• Major molecular remission by polymerase chain reaction for BCR-ABL — Up to 100 days after treatment start
  Major molecular remission (MMR), also known as MR3.0, is defined as BCR-ABL transcript levels (expressed as a percentage compared with the ABL control gene) ≤ 0.1% based on PCR at day 85.

Countries

United States