Asciminib for Acute Lymphoblastic Leukemia

Enrolling by invitation at 1 trial location

Overseen By SWOG Clinical Trials Partnerships

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: SWOG Cancer Research Network

Must not be taking: Immunosuppressants, Monoclonal antibodies, PPIs, others

Disqualifiers: CNS pathology, Uncontrolled infection, 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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL), a type of blood cancer, by adding the drug asciminib to traditional chemotherapy. Researchers aim to determine if this combination is more effective than the standard treatment. This trial may suit those newly diagnosed with Ph+ ALL who have the specific chromosome marker and cannot or choose not to undergo intensive chemotherapy. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.

Is there any evidence suggesting that asciminib is likely to be safe for humans?

Research has shown that asciminib holds promise for treating Philadelphia chromosome-positive (Ph+) leukemias, including acute lymphoblastic leukemia (ALL). Previous studies have found that asciminib has minimal toxicity, causing few harmful side effects. One study found that combining asciminib with other drugs like dasatinib and prednisone is safe for patients with Ph+ acute leukemia. This suggests that asciminib is generally well-tolerated and could offer a safer treatment option for this type of leukemia. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Asciminib is unique because it targets the BCR-ABL1 protein with a novel mechanism of action, which is different from the standard chemotherapy or tyrosine kinase inhibitors typically used for acute lymphoblastic leukemia (ALL). Unlike most therapies that bind to the ATP-binding site of the BCR-ABL1 protein, asciminib specifically targets the myristoyl pocket, offering a more precise way to inhibit cancer cell growth. Researchers are excited because this could lead to fewer side effects and improve treatment efficacy for patients with ALL, especially those who are resistant to other therapies.

What evidence suggests that asciminib might be an effective treatment for Acute Lymphoblastic Leukemia?

Research has shown that asciminib may effectively treat certain types of leukemia, such as acute lymphoblastic leukemia (ALL), which have a specific genetic marker called the Philadelphia chromosome. In some studies, about 45% of patients experienced a significant reduction in their cancer. Even those who had tried other treatments, like ponatinib, showed improvements with asciminib. Other research found that about half of the patients had better overall health with asciminib compared to standard treatments. These results suggest that asciminib could be a useful addition to current ALL treatments. ^{2 5 6 7 8}

Who Is on the Research Team?

Anjali S Advani

Principal Investigator

SWOG Network Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with a new diagnosis of Ph+ ALL who are either over 60 years old or under 60 but not suitable for standard chemotherapy. They must have recovered from any major surgery effects, have no central nervous system involvement, and show at least 20% lymphoblasts in blood or bone marrow tests.

Inclusion Criteria

My leukemia is confirmed to be Philadelphia chromosome positive.

I am 60 or older, or under 60 and cannot or will not undergo standard chemotherapy.

I have had a spinal tap to check for leukemia in my brain or spinal cord within the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive Asciminib, Dasatinib, and Prednisone for up to 12 weeks, with response assessments at 4-week intervals.

12 weeks

Weekly visits for monitoring and response assessment

Re-induction Treatment

Participants receive Blinatumomab and Dasatinib for up to 12 weeks if initial induction does not achieve remission.

12 weeks

Weekly visits for monitoring and response assessment

Post-remission Treatment

Participants receive Blinatumomab and Dasatinib in 42-day cycles for up to 18 weeks.

18 weeks

Cycle-based visits for treatment and monitoring

Maintenance Treatment

Participants receive Asciminib, Dasatinib, and Prednisone in 28-day cycles for up to five years, or until disease progression or unacceptable toxicity.

Up to 5 years

Monthly visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

Up to 5 years

Every 3 months for the first 2 years, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Asciminib

Trial Overview

The study is testing whether adding asciminib to the usual treatment can improve outcomes for patients with Ph+ Acute Lymphoblastic Leukemia compared to the standard approach.

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Novartis Pharmaceuticals

Industry 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

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1.

ashpublications.org

ashpublications.org/blood/article/146/Supplement%201/3357/548642/Real-world-outcomes-of-asciminib-in-relapsed

Real world outcomes of asciminib in relapsed/refractory ...

Overall, 9 out of 20 patients (45%) achieved a successful molecular response. Among patients previously treated with ponatinib (n=18), 7 (39%) ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2473952925003787

Asciminib for relapsed or refractory Philadelphia ...

Ponatinib vs imatinib in frontline Philadelphia chromosome–positive acute lymphoblastic leukemia: a randomized clinical trial. JAMA, 331 (21) ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12482290/

Asciminib and inotuzumab ozogamicin: a new combination ...

Improved outcome for children with acute lymphoblastic leukemia: results of Dana-Farber Consortium Protocol 91-01. Blood. 2001;97(5):1211 ...

4.

haematologica.org

haematologica.org/article/view/12134

Asciminib for Philadelphia chromosome-positive leukemias

Studies have demonstrated the safety and efficacy of asciminib in patients with resistance or intolerance to two or more lines of prior therapy ...

5.

hmpgloballearningnetwork.com

hmpgloballearningnetwork.com/site/onc/conference-coverage/asciminib-shows-improved-patient-outcomes-vs-investigator-selected

Asciminib Shows Improved Patient Outcomes vs ...

~50% of asciminib-treated patients improved in global health, while only 10 to 15% worsened versus ~33% worsening in the control arm. Clinical ...

6.

ashpublications.org

ashpublications.org/blood/article/145/6/551/535335/Asciminib-for-Ph-ALL-a-step-forward

Asciminib for Ph + ALL: a step forward? - ASH Publications

Their dose-finding study provides firm evidence for the feasibility and safety of this drug combination for patients with newly diagnosed Ph+ ...

7.

hematologyadvisor.com

hematologyadvisor.com/news/acute-leukemia-asciminib-dasatinib-prednisone-safe-treatment-risk/

Asciminib Plus Dasatinib and Prednisone Safe With ...

Researchers determined asciminib plus dasatinib and prednisone was safe and showed activity for patients with Ph+ acute leukemia.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02081378

NCT02081378 | A Phase I Study of Oral Asciminib ...

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 ...