Asciminib for Chronic Myeloid Leukemia

Overseen By Ghayas C. Issa

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Tyrosine kinase inhibitors

Must not be taking: QT-prolonging drugs

Disqualifiers: Heart failure, Myocardial infarction, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 36 months

7 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well ABL001 works in treating patients with chronic myeloid leukemia who are on therapy with tyrosine kinase inhibitor. ABL001 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ABL001 and tyrosine kinase inhibitor together may work better than tyrosine kinase inhibitor alone in treating patients with chronic myeloid leukemia.

Research Team

Ghayas Issa, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for chronic myeloid leukemia patients who've been on tyrosine kinase inhibitor therapy for at least 2 years without needing changes in the last 6 months. They must have certain levels of disease markers and normal organ function tests. Pregnant women, those with severe heart conditions or infections like HIV, and anyone with a history of pancreatitis or other active cancers are excluded.

Inclusion Criteria

Creatinine =<1.5 x institutional upper limit of normal

I agree to use effective birth control during and after the study.

I've been on TKI therapy for 2+ years without changes in the last 6 months.

Exclusion Criteria

I have had a heart attack or severe heart issues in the last 6 months.

I am allergic or have had a bad reaction to ABL001 or its ingredients.

I am not taking strong medication that affects liver enzymes or cannot stop it before starting the study treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive asciminib orally twice daily for up to 36 months while receiving standard of care dasatinib or nilotinib

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

6 months

Every 4-8 weeks

Long-term follow-up

Participants are monitored every 3-6 months for long-term outcomes

Up to 6 years

Treatment Details

Interventions

• Asciminib

Trial Overview The study is testing ABL001's effectiveness when combined with tyrosine kinase inhibitors in treating chronic myeloid leukemia. It aims to see if this combination works better than the inhibitor alone by blocking enzymes that cancer cells need to grow.

Participant Groups

Group I: Treatment (asciminib) Experimental Treatment 1 Intervention

Patients receive asciminib PO BID for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+