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ABL001

DRUG3 trials

Sponsors

Novartis Pharmaceuticals, Marlise Luskin, MD

Conditions

B-cell Acute Lymphoblastic LeukemiaChronic Myelogenous Leukemia - Chronic PhaseChronic Myeloid Leukemia (CML) in Lymphoid Blast CrisisHepatic ImpairmentPhiladelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph+ ALL

Phase 1

A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
CompletedNCT02857868
Novartis PharmaceuticalsHepatic Impairment
Start: 2016-05-03End: 2017-07-20Updated: 2020-12-08
ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
RecruitingNCT03595917
Marlise Luskin, MDB-cell Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia (CML) in Lymphoid Blast Crisis, Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph+ ALL
Start: 2018-07-24End: 2027-11-01Target: 40Updated: 2025-11-04

Phase 3

Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
CompletedNCT04666259
Novartis PharmaceuticalsChronic Myelogenous Leukemia - Chronic Phase
Start: 2021-05-25End: 2024-06-26Updated: 2025-10-16

Related Papers

A phase I study of asciminib in combination with dasatinib, prednisone, and blinatumomab for Ph-positive acute leukemia in adults.
Journal of Clinical Oncology2025-05-281 citations
Abstract 5145: E-selectin binding is enriched within B-cell acute lymphoblastic leukemia compared to healthy lymphoid precursors
Cancer Research2025-04-21
Asciminib monotherapy in patients with chronic myeloid leukemia in chronic phase without BCR::ABL1<sup>T315I</sup> treated with at least 2 prior TKIs: Phase 1 final results.
2025-04-093 citations
A Phase I Study of Asciminib (ABL001) in Combination with Dasatinib and Prednisone for BCR-ABL1-Positive ALL and Blast Phase CML in Adults
Blood2023-11-0213 citations
Asciminib (ASC) Once-Daily (QD) Dosing Demonstrates Comparable Tolerability and Efficacy to Twice-Daily (BID) Dosing: Results from the ASC in Monotherapy 4 CML (AIM4CML) Study in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
Blood2023-11-02
Justification for Asciminib Dosing in Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML-CP) with and without the T315I Mutation
Blood2022-11-152 citations
Population Pharmacokinetics in Hepatic and Renal Impairment and PBPK Drug-Drug Interaction Simulations of Asciminib, a Novel Tyrosine Kinase Inhibitor in Chronic Myeloid Leukemia in Chronic Phase
Blood2022-11-15
A Phase I Study of Asciminib (ABL001) in Combination with Dasatinib and Prednisone for BCR-ABL1-Positive ALL in Adults
Blood2021-11-0515 citations
Trial in Progress: Asciminib in Monotherapy 4 CML (AIM4CML), a Phase IIIb Study of Asciminib Monotherapy in Patients with Chronic Myeloid Leukemia in Chronic Phase without or with T315I Mutations
Blood2021-11-052 citations
Pharmacokinetics of Asciminib in Individuals With Hepatic or Renal Impairment
The Journal of Clinical Pharmacology2021-06-1123 citations
A Phase I Study of Asciminib (ABL001) in Combination with Dasatinib and Prednisone for Untreated BCR-ABL1-Positive ALL in Older Adults
Blood2019-11-137 citations