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

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

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

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

See 2 more

Treatment Details

Interventions

ABL001 (Tyrosine Kinase Inhibitor)
Dasatinib (Tyrosine Kinase Inhibitor)
Imatinib (Tyrosine Kinase Inhibitor)
Nilotinib (Tyrosine Kinase Inhibitor)

Participant Groups

5Treatment groups

Experimental Treatment

Group I: Asciminib+dasatinib in CML patientsExperimental Treatment2 Interventions

Dose escalation study estimated the MTD and/or RDE of asciminib in combination with dasatinib in adult CML patients

Group II: Asciminib+Nilotinib in CML patientsExperimental Treatment2 Interventions

Dose escalation study estimated the MTD and/or RDE of asciminib in combination with Nilotinib in adult CML patients

Group III: Asciminib+Imatinib in CML patientsExperimental Treatment2 Interventions

Dose escalation study to estimate the MTD and/or RDE of asciminib in combination with imatinib in adult CML patients

Group IV: Asciminib in Ph+ ALL patientsExperimental Treatment1 Intervention

Dose escalation study estimated the MTD and/or RDE of asciminib in adult patients with Ph positive ALL patients

Group V: Asciminib in CML patientsExperimental Treatment1 Intervention

Dose escalation study estimated the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of asciminib in adult patients with chronic myeloid leukemia (CML).