USO 22283

A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (CABL001J12302)

Disease Types: Leukemia & Lymphoma Research

Eligibility Requirements:

Eligibility Criteria:

- Patients with CML-CP within 3 months of diagnosis.

- Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of the Philadelphia chromosome.

- Evidence of typical BCR::ABL1 transcript which is amenable to standardized RQ-PCR quantification by the central laboratory assessment.

- ECOG performance status of 0 or 1.

-  Adequate end organ function.  

- Patients must have the following laboratory values within normal limits or corrected to within normal limits with supplements prior to randomization:

  Potassium 

  Total calcium 

  Magnesium 

Available at:

• Chesapeake
• Hampton (CarePlex)
• Newport News (Port Warwick III)
• Norfolk (Brock Cancer Center)
• Virginia Beach (Princess Anne)