104 Participants Needed

Asciminib + Imatinib for Chronic Myeloid Leukemia

Recruiting at 30 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Novartis Pharmaceuticals
Must be taking: Imatinib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib versus asciminib 80mg in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP)

Who Is on the Research Team?

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Chronic Myeloid Leukemia in chronic phase (CML-CP) who have been treated with imatinib for at least a year and haven't achieved deep molecular response. They must meet specific blood, liver, and kidney health criteria. Excluded are those with heart issues, history of pancreatitis or other cancers within the last 3 years, or previous treatment failures on imatinib.

Inclusion Criteria

I have been treated with imatinib for at least a year for my CML-CP.
Patient must meet specific laboratory values before randomization: Absolute Neutrophil Count ≥ 1.5 x 10E9/L, Platelets ≥ 75 x 10E9/L, Hemoglobin ≥ 9 g/dL, Serum creatinine < 1.5 mg/dL, Total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's syndrome), Aspartate transaminase (AST) ≤ 3.0 x ULN, Alanine transaminase (ALT) ≤ 3.0 x ULN, Alkaline phosphatase ≤ 2.5 x ULN, Serum lipase ≤ 1.5 x ULN. Patients must have other laboratory values within normal limits or corrected with supplements prior to randomization.
In Korea, I've been treated with imatinib for at least 1 or 2 years based on my BCR-ABL levels.
See 3 more

Exclusion Criteria

History or current diagnosis of ECG abnormalities indicating significant risk or safety for subjects participating in the study
I haven't had any other cancer besides this one in the last 3 years.
I have been treated with a tyrosine kinase inhibitor other than imatinib.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive randomized treatment with asciminib in combination with imatinib, continued imatinib, or switch to nilotinib for up to 96 weeks

96 weeks

Cross-over

Participants on the imatinib continuation arm who have not achieved MR4.5 at 48 weeks may cross-over to receive asciminib 60 mg combination add-on treatment

4 weeks after week 48

Follow-up

Participants are monitored for safety for 30 days after the last dose received

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Asciminib
  • Imatinib
  • Nilotinib
Trial Overview The study tests the effectiveness and safety of adding Asciminib to Imatinib versus continuing only Imatinib or switching to Nilotinib or using Asciminib alone in patients previously treated for CML-CP. It also examines how these drugs interact within the body.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Asciminib 60mg QD + Imatinib 400mg QDExperimental Treatment2 Interventions
Group II: Asciminib 40mg QD + Imatinib 400mg QDExperimental Treatment2 Interventions
Group III: Imatinib 400mg QDActive Control1 Intervention
Group IV: Nilotinib 300mg BIDActive Control1 Intervention

Asciminib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Scemblix for:
🇪🇺
Approved in European Union as Scemblix for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

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