Chronic Myelogenous Leukemia (ASCEMBL)

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Chronic Myelogenous Leukemia (ASCEMBL)

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib (ABL001) Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors.

Overview

This Study Is Active, Not Recruiting: Phase III Actual Start Date: [October 26, 2017] Estimated Completion Date: [March 19, 2025] Novartis Reference Number: CABL001A2301
Condition: Chronic Myelogenous Leukemia in Chronic Phase Interventions: asciminib, bosutinib Estimated Enrollment: [222 participants] ClinicalTrials.gov Identifier: NCT03106779
This Study Is Active, Not Recruiting: Phase III Actual Start Date: [October 26, 2017]
Estimated Completion Date: [March 19, 2025] Novartis Reference Number: CABL001A2301
Condition: Chronic Myelogenous Leukemia in Chronic Phase Interventions: asciminib, bosutinib
Estimated Enrollment: [222 participants] ClinicalTrials.gov Identifier: NCT03106779

Study Goal

The purpose of this study is to compare the efficacy of asciminib with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs.

Patients intolerant to the most recent TKI therapy must have BCR-ABL1 ratio > 0.1% IS at screening and patients failing their most recent TKI therapy must meet the definition of treatment failure as per the 2013 ELN guidelines.

Patients with documented treatment failure while on bosutinib treatment will have the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Eligibility

Participants may be eligible to participate if they:

  • Are 18 years or older
  • Have a confirmed diagnosis of CML-CP
  • Have prior treatment with a minimum of 2 prior ATP-binding site TKIs (i.e. imatinib, nilotinib, dasatinib, radotinib or ponatinib)
  • Have failure (per ELN guidelines) or intolerance to the most recent TKI therapy
  • Have a BCR-ABL1 ratio ≥ 0.1% IS, for patients intolerant to the most recent TKI therapy
  • Meet other eligibility criteria

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

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Still Have a Question?

Are you a Patient, Caregiver or Health Care Professional looking for more information?

To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.

Other chronic myelogenous leukemia trials you might be interested in:

A Phase II, Multicenter, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.

Definitions:
ATP - Adenosine triphosphate, BCR-ABL1 - Breakpoint cluster region-Abelson murine leukemia, CML-CP - Chronic myelogenous leukemia in chronic phase, ELN - European LeukemiaNet, ICF - Informed consent form, IS - International Scale, TKI - Tyrosine kinase inhibitor

Last Updated: October 7, 2019

10/19 M-GON-1220483