Adding Asciminib to Standard Treatment for Adults with Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Sponsor: SWOG Cancer Research Network

Sponsor score: 0

ClinicalTrials ID:NCT06773936

This study is exploring whether adding the drug asciminib to the usual treatment can improve the effectiveness of chemotherapy for patients with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL).

Patient Parameters

Parameter	Options

Program Overview

This phase II clinical trial aims to find out if adding the study drug asciminib to the usual treatment can make chemotherapy more effective against Ph+ Acute Lymphoblastic Leukemia (ALL) and if this approach is better than the standard treatment for Ph+ALL.

Description

Primary Goals:

To see if adding asciminib to the treatment helps achieve a major reduction in leukemia cells by day 85 in patients with newly diagnosed Ph+ ALL.

Secondary Goals:

To estimate how many patients achieve complete remission by day 85.
To track how long patients remain free of disease and their overall survival.
To monitor the side effects and their severity.
To measure the reduction of leukemia cells using different methods.
To compare the effectiveness of different methods in measuring leukemia cell reduction.
To estimate the chances of relapse after achieving a major reduction in leukemia cells.
To track the duration of remission and time to treatment failure.
To describe survival without events related to leukemia.

Research Goals:

To study the genes and pathways involved in the response to treatment.
To observe mutations in resistant or relapsed samples.
To collect specimens for future research.

Treatment Plan:

Phase 1 (Induction): Up to 12 weeks of treatment with asciminib and other drugs. Patients will be tested after 4 weeks to see if leukemia is responding. If leukemia is not detected, treatment continues for 8 more weeks. If leukemia is still present, additional treatment is given.
Phase 2 (Post-Remission): Up to 18 weeks of treatment in 42-day cycles with Blinatumomab and Dasatinib. Patients are tested after treatment to check for leukemia.
Phase 3 (Maintenance): Ongoing treatment in 28-day cycles with asciminib, Dasatinib, and Prednisone for up to five years or until leukemia returns or side effects become too severe.

After treatment, patients will have follow-up visits every 3 months for the first two years, and every 6 months until five years after treatment ends.

Eligibility Criteria

Inclusion Criteria

Must have a new diagnosis of Philadelphia chromosome positive (Ph+) ALL confirmed by specific tests.
Must have evidence of CD19+ ALL in blood or bone marrow with at least 20% lymphoblasts.
Must be 60 years or older, or if younger, not suitable for standard intensive chemotherapy.
Must have a lumbar puncture to check for CNS involvement of ALL.
Must have completed medical history and physical exam.
Must have a performance status score of 0-3.
Must have adequate pancreatic, liver, and cardiac function.
Must be able to take oral medications.
Must have controlled chronic hepatitis B, HIV, or hepatitis C if applicable.
Must agree to provide blood and bone marrow samples for research.

Exclusion Criteria

Must not have a known lymphoid blast crisis of CML or have received previous TKI therapy for CML.
Must not have received prior chemotherapy or other treatments for ALL, except for specific short-term treatments.
Must not be receiving immunosuppressive therapy.
Must not have had a prior stem cell transplant.
Must not have significant CNS pathology or active CNS leukemia.
Must not have uncontrolled infections or significant fluid buildup in the body.
Must not be pregnant or nursing and must agree to use effective contraception if of reproductive potential.
Must not have significant autoimmune disease or be taking proton pump inhibitors.
Must not have gastrointestinal issues that affect drug absorption.
Must not have a history of pancreatitis or ongoing pancreatic disease.
Must not have uncontrolled illnesses.

Locations

FACILITY	ZIP	CITY	STATE
UV Irvine Medical Center	92868	Orange	California
Northwell Health/Center for Advanced Medicine	11042	Lake Success	New York
Duke University Medical Center	27710	Durham	North Carolina
University of Cincinnati Cancer Ctr-UC Medical Ctr	45267	Cincinnati	Ohio
Cleveland Clinic Foundation	44195	Cleveland	Ohio
Baptist Memorial Health Care	38120	Memphis	Tennessee

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