← Back to Search

Tyrosine Kinase Inhibitor

Asciminib for Chronic Myelogenous Leukemia

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At any time after the initiation of therapy BCR-ABL1 >1% IS, emergence of resistance mutations, high-risk ACA

In addition, patients with failure of treatment according to the ELN 2020 recommendations will be eligible:

Must not have

Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:

History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4, 12, 24, 48, 72, 96, 120 and at end of treatment (up to 144 weeks).

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study the effectiveness of asciminib in patients with CML who have already been treated with two other TKIs.

Who is the study for?

This trial is for adults with chronic myelogenous leukemia in chronic phase (CML-CP) who have tried at least two Tyrosine Kinase Inhibitors without success or cannot tolerate them. They must not have had a stem-cell transplant, plan to undergo one soon, or have certain heart conditions or severe medical issues.

What is being tested?

The study aims to find the best dose of asciminib for treating CML-CP after failure with other treatments. Patients will take either 40 mg twice daily or 80 mg once daily of asciminib and their response will be monitored according to specific criteria.

What are the potential side effects?

Asciminib may cause side effects such as low blood cell counts leading to increased infection risk, bleeding problems, fatigue, liver issues, and possibly pancreatitis. Heart rhythm problems are also a concern.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer has shown resistance or high-risk changes after starting treatment.

Select...

My treatment failed according to the 2020 ELN guidelines.

Select...

I've had severe blood-related side effects from treatment, even after the dose was lowered.

Select...

I am 18 or older with chronic myeloid leukemia in the chronic phase.

Select...

My cancer markers increased after starting treatment.

Select...

I have been treated with at least 2 types of TKI medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have Long QT syndrome or a family history of sudden death.

Select...

I have had acute pancreatitis in the last year or have chronic pancreatitis.

Select...

I do not have serious heart rhythm problems.

Select...

I have an ongoing liver condition.

Select...

I am planning to have a stem cell transplant from a donor.

Select...

My cancer has the BCR-ABL1 T315I mutation.

Select...

I do not have any heart or heart rhythm problems.

Select...

I have had a stem-cell transplant before.

Select...

I have a history of arterial or venous blood clots.

Select...

I have risk factors for a specific heart rhythm problem due to low potassium or magnesium, heart failure, or slow heartbeat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4, 12, 24, 48, 72, 96, 120 and at end of treatment (up to 144 weeks).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4, 12, 24, 48, 72, 96, 120 and at end of treatment (up to 144 weeks).

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, 12, 24, 48, 72, 96, 120 and at end of treatment (up to 144 weeks). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Major molecular response (MMR) rate at Week 48 for all patients with no evidence of MMR at baseline.

Secondary study objectives

Change in symptom burden and interference from baseline over time according to the MDASI-CML PRO instrument.

Cumulative molecular response rate of BCR-ABL1 ≤ 10%.

Cumulative molecular response rate of BCR-ABL1 ≤1%.

+17 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ABL001Experimental Treatment3 Interventions

Participants will be treated with 80 mg of ABL001 (40 mg BID or 80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.

0 / 16Eligibility criteria met