A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL

Completed · Phase 1

Conditions studied: Chronic Myelogenous Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

In brief

The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in Chronic myeloid leukemia (CML) and Philadelphia chromosome positive Acute lymphoblastic leukemia (Ph+ ALL) patients who are relapsed or refractory to or are intolerant of Tyrosine kinase inhibitors (TKIs), and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.

Key facts

Study ID

NCT02081378

Run by

Novartis Pharmaceuticals

People needed

326

Starts

2014-04-24

Expected to finish

2023-03-14

Last updated by the study team

2024-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For CML patients either:
• a. Patients with Ph+ CML in chronic or accelerated phase who were previously treated with at least two different tyrosine kinase inhibitors prior to study entry and are relapsed, refractory to or intolerant of TKIs as determined by investigators or
• b. Patients with CML in chronic or accelerated phase who exhibit relapsed disease associated with the presence of the T315I "gatekeeper mutation" after at least one TKI are also eligible provided that no other effective therapy exists
• For ALL and CML-BP patients:
• Patients with CML BP or Ph+ ALL who have a cytopathologically confirmed diagnosis and are relapsed or refractory to at least one prior TKI or intolerant of TKIs. TKI failure for Ph+ ALL and CML-BP patients is defined as at least the loss of Molecular Response (MR) 4.5 (BCR-ABL ≤ 0.0032%)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Willingness and ability to comply with all study procedures
• Written informed consent obtained prior to any screening procedures

You may not qualify if…

• Wash-out period:
• Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon and toxin immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is shorter, before the first dose of study treatment
• Therapy with TKIs as single agent within 5 half-lives before the first dose of study treatment
• Unconjugated monoclonal antibody therapies within 28 days or 5 half-lives, whichever is shorter, before the first dose of study treatment
• For patients receiving ABL001 in combination with either nilotinib or imatinib or dasatinib, intolerance to nilotinib, imatinib or dasatinib, respectively
• Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment.
• CNS irradiation for meningeal leukemia, except if radiotherapy occurred > 3 months previously. At least four weeks must have elapsed since prophylactic CNS irradiation given as part of a front-line therapy regimen for ALL
• Major surgery within 2 weeks before the first dose of study treatment

Where it is running

• Dana Farber Cancer Institute Hematology / Oncology — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center SC — Ann Arbor, Michigan, United States
• Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering — New York, New York, United States
• Oregon Health Sciences University SC-6 — Portland, Oregon, United States
• University of Texas/MD Anderson Cancer Center UT MD Anderson — Houston, Texas, United States
• Huntsman Cancer Institute SC — Salt Lake City, Utah, United States
• Novartis Investigative Site — Adelaide, South Australia, Australia
• Novartis Investigative Site — Paris, Cedex 10, France
• Novartis Investigative Site — Bordeaux, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Jena, Germany
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Kobe, Hyōgo, Japan
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Seoul, Seocho Gu, South Korea
• Novartis Investigative Site — Madrid, Spain

Full record on ClinicalTrials.gov

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