Adding Asciminib to Usual Treatment for Adults With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia
brief 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?"
detailed description
PRIMARY OBJECTIVES:
I. To assess the rate of major molecular remission (MMR) by polymerase chain reaction (PCR) for BCR-ABL at day 85 in newly diagnosed participants with Philadelphia-chromosome positive Ph+ acute lymphoblastic leukemia (ALL) treated with asciminib, dasatinib and prednisone.
SECONDARY OBJECTIVES:
I. To estimate the rate of complete remission (with and without complete count recovery, CR/CRi) at day 85 in this participant population.
II. To describe disease-free survival (DFS) in this participant population. III. To estimate overall survival (OS) in this participant population. IV. To estimate the frequency and severity of toxicities in this participant population.
V. To estimate the rate of measurable residual disease remission by flow cytometry (MRD Flow) at day 85 in this participant population.
VI. To compare rates of MMR by PCR and MRD flow remission in this participant population.
VII. Among participants who achieve MMR, to estimate the cumulative incidence of relapse from MMR in this participant population.
VIII. To describe attainment and failure of MR3.0, MR4.0 and MR4.5 at day 85 in this participant population.
IX. To estimate the rate of complete remission with undetectable MRD levels by flow cytometry (MRDundetectable CR) in this participant population.
X. To estimate duration of MMR in this participant population. XI. To estimate duration of MR4.0 in this participant population. XII. To estimate time to treatment failure in this participant population. XIII. To describe event-free survival (EFS) in this participant population.
TRANSLATIONAL MEDICINE OBJECTIVES:
I. To evaluate and describe the genes and pathways associated with response (molecular response) to therapy.
II. To describe the spectrum of mutations observed, and the timing of their emergence, in resistant/relapse samples.
III. To bank specimens for future correlative studies.
official title
A Phase II Trial of Asciminib, Dasatinib, Prednisone, and Blinatumomab for Participants With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia