A Phase II Trial of Asciminib, Dasatinib, Prednisone, and Blinatumomab for Participants with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia
Categories (click each to see list of all clinical trials associated with that category): Leukemia/MDS/MPD (ONC)
Current Status: Not open
Phase: II
Principal Investigator: Gundabolu, Krishna
Contact Information:
Krista Patterson
kpatterson@unmc.edu
Summary
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.