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Philadelphia Chromosome Positive Acute Lymphoblastic LeukemiaPhase 2NCT06773936

Adding Asciminib to Usual Treatment for Adults With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia

A Phase 2 study testing Induction Phase, Re-Induction Phase and Post-Remission in people with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia and CD19+ Acute Leukemia, run by SWOG Cancer Research Network at 16 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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Trial summary

This phase II trial is to answer the question of "can adding the study drug, asciminib to usual treatment improve how chemotherapy works against Ph+ Acute Lymphoblastic Leukemia (ALL) and is this approach better than the usual approach for Ph+ALL?" Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Induction Phase, Re-Induction Phase and Post-Remission
How many people
55 participants
Where
16 sitesUnited States
Study dates
13 Apr 2026to Jul 2033
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have a new diagnosis of Philadelphia chromosome positive (Ph+) ALL by cytogenetics, FISH, or polymerase chain reaction (PCR). Diagnostic specimens must be submitted to the site's local CLIA-approved cytogenetics laboratory and results (cytogenetics, FISH, or PCR) must confirm Ph status prior to registration.
  • Participants must have BCR-ABL status (p190 or p210) performed but results don't need to be back prior to Step 1 registration.
  • Participants must have evidence of CD19+ ALL in their marrow or peripheral blood with at least 20% lymphoblasts present in blood or bone marrow collected within 28 days prior to registration. Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage. Appropriate marker studies including CD19 (B cell) must be performed. If a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate Immunohistochemistry (IHC) testing, including CD19, must be performed on the bone marrow biopsy to determine lineage. Participants with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible. CD19+ is defined as > 20% expression by flow cytometry or IHC.
  • Participants must have recovered from any prior major surgery adverse effects within 14 days prior to registration, to the satisfaction of the local investigator.
  • Participants must be ≥ 60 years old, or, if participants are under 60 years of age, they are not suitable for standard intensive induction chemotherapy at the discretion of the local investigator or must have refused standard intensive chemotherapy.
  • Participants must have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration. Note that intrathecal methotrexate administered during the pre-study lumbar puncture may count as the first dose of intrathecal therapy required as part of the study.
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  • Participants must have completed medical history and physical exam within 28 days prior to registration.
  • Participants must have Zubrod/ECOG Performance Status of 0-3.
  • Participants with extramedullary disease at diagnosis must have an MRI or CT scan with contrast of chest, neck, abdomen, pelvis, or whole body to obtain baseline values within 28 days prior to registration.
  • Participants must have adequate pancreatic and liver function within 14 days prior to registration
  • Participants must have a calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 14 days prior to registration.
  • Participants must have adequate cardiac function.
  • Participants must be able to take oral medications and comply with the oral regimen.
  • Participants with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated.
  • Participants with known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration.
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants must have an undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated.
  • Participants must agree to have peripheral blood and bone marrow specimens submitted for translational studies.
  • Participants must be offered the opportunity to participate in specimen. banking

Who cannot join

  • Participants must not have known lymphoid blast crisis of CML or have received previous TKI therapy for their CML.
  • Participants must not have received any prior chemotherapy, investigational agents, radiation therapy, or other therapy for the treatment of ALL other than the following for a maximum of 7 days: FDA-approved TKI therapy, steroids, hydroxyurea, leukapheresis, and intrathecal chemotherapy.
  • Participants must not be receiving any immunosuppressive therapy.
  • Participants must not have received a prior autologous or allogeneic hematopoietic stem cell transplant.
  • Participants must not have received any monoclonal antibody therapy within 42 days prior to registration.
  • Participants must not have a history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, active ALL in the CNS confirmed by CSF analysis, or other significant CNS abnormalities.
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  • Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen (in the opinion of the treating physician).
  • Participants must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) as determined by the local investigator.
  • Participants must not have clinically significant pericardial effusion, ascites or pleural effusion based on chest CT or x-ray or echocardiogram within 28 days prior to registration. Exceptions: if the effusion is suspected to be related to leukemia, the participant may have pericardial effusion ≤ Grade 2 or pleural effusion ≤ Grade 1.
  • Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
  • Participants must not have clinically significant autoimmune disease.
  • Participants must not be receiving any proton pump inhibitors at the time of registration.
  • Participants must not have impairment of gastrointestinal function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome). Participants who have had a gastrectomy are eligible.
  • Participants must not have a history of or current acute pancreatitis, chronic pancreatitis, or any ongoing pancreatic disease.
  • Participant must not have uncontrolled intercurrent illness.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

16 sites in 1 country

United States16 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • University of Cincinnati Cancer Ctr-UC Medical Ctr

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • Baptist Memorial Health Care

    Memphis, Tennessee, 38120

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • UC Irvine Medical Center

    Orange, California, 92868

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719

Other trials in United States

About this study

Official title: A Phase II Trial of Asciminib, Dasatinib, Prednisone, and Blinatumomab for Participants With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia

This phase II trial is to answer the question of "can adding the study drug, asciminib to usual treatment improve how chemotherapy works against Ph+ Acute Lymphoblastic Leukemia (ALL) and is this approach better than the usual approach for Ph+ALL?"

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the rate of major molecular remission (MMR) by polymerase chain reaction (PCR) for BCR-ABL at day 85 in newly diagnosed participants with Philadelphia-chromosome positive Ph+ acute lymphoblastic leukemia (ALL) treated with asciminib, dasatinib and prednisone.

SECONDARY OBJECTIVES:

  1. To estimate the rate of complete remission (with and without complete count recovery, CR/CRi) at day 85 in this participant population.

II. To describe disease-free survival (DFS) in this participant population. III. To estimate overall survival (OS) in this participant population. IV. To estimate the frequency and severity of toxicities in this participant population.

  1. To estimate the rate of measurable residual disease remission by flow cytometry (MRD Flow) at day 85 in this participant population.

VI. To compare rates of MMR by PCR and MRD flow remission in this participant population.

VII. Among participants who achieve MMR, to estimate the cumulative incidence of relapse from MMR in this participant population.

VIII. To describe attainment and failure of MR3.0, MR4.0 and MR4.5 at day 85 in this participant population.

IX. To estimate the rate of complete remission with undetectable MRD levels by flow cytometry (MRDundetectable CR) in this participant population.

  1. To estimate duration of MMR in this participant population. XI. To estimate duration of MR4.0 in this participant population. XII. To estimate time to treatment failure in this participant population. XIII. To describe event-free survival (EFS) in this participant population.

TRANSLATIONAL MEDICINE OBJECTIVES:

  1. To evaluate and describe the genes and pathways associated with response (molecular response) to therapy.

II. To describe the spectrum of mutations observed, and the timing of their emergence, in resistant/relapse samples.

III. To bank specimens for future correlative studies.

OUTLINE: Patients will have their phase of treatment determined by their responses tested by blood and bone marrow tests.

PHASE 1 TREATMENT (INDUCTION):

Phase 1 treatment may last up to 12 weeks. Patients will start with 4 weeks of treatment. Patients will receive Asciminib every day with a combination of other drugs. After 4 weeks of Phase 1 treatment, patients will be testing to see how the leukemia is responding. If There are no more signs of leukemia, the patients will receive 8 more weeks of Phase 1 treatment. if there are still signs of leukemia, patients will receive 4 more weeks of Phase 1 treatment and then will be tested again. If there are no signs of leukemia, they will receive 4 more weeks of Phase 1 treatment for a total of 12 weeks. If there are no signs of leukemia, patients will start Phase 2 treatment. If there are still signs of leukemia, the patients will start Re-induction treatment. Re-Induction treatment may last up to 12 weeks. Patients will start with 6 weeks of treatment. Patients will receive Blinatumomab every day for 28 days and Dasatinib every day for 42 days. After weeks of treatment, patients are tested and if there are no signs of leukemia, patients will start Phase 2 treatment. If there are still signs of leukemia, patients will repeat 6 weeks of Re-induction treatment. After repeating 6 weeks of Re-induction treatment if there are no signs of leukemia, patients will start Phase 2 treatment. If there are still signs of leukemia, patients will stop treatment in the study.

PHASE 2 TREATMENT (POST-REMISSION):

Phase 2 treatment will last up to 18 weeks. Patients will receive treatment in cycles of 42 days. There are 3 cycles of Phase 2 treatment. Patients will receive Blinatumomab every day for days 1-28 of each cycle and Dasatinib every day of each cycle. After Phase 2 treatment, patients will be tested. If there are no signs of leukemia, patients will start Phase 3 treatment. If there are signs of leukemia, patients will stop treatment in the study.

PHASE 3 TREATMENT (MAINTENANCE):

Patients will receive maintenance treatment for as long as it helps them. Phase 3 Treatment is given in 28-day cycles. Patients will receive Asciminib every day of each cycle, for up to five years from the time they started the study. Patients will take Dastinib every day of each cycle for as long as it helps them and Prednisone days 1-5 of each cycle for 18 cycles. Patients will stop treatment if the leukemia comes back or if side effects become too severe.

After completion of study treatment, patients are followed up on every 3 months for the first two years, and every 6 months until five years after treatment ends.

Being tested
Induction Phase, Re-Induction Phase, Post-Remission, Maintenance
Keywords
PH+ALL, ALL, Philadelphia Chromosome Positive, Acute Lymphoblastic Leukemia
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Induction PhaseDrug

    Asciminib, Dasatinib, Prednisone, and Methotrexate

  • Re-Induction PhaseDrug

    Blinatumomab, Dasatinib, Methotrexate, and Dexamethasone

  • Post-RemissionDrug

    Blinatumomab, Dasatinib, Methotrexate and Dexamethasone

  • MaintenanceDrug

    Asciminib, Dasatinib, Prednisone, and Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major molecular remission by polymerase chain reaction for BCR-ABL

    Major molecular remission (MMR), also known as MR3.0, is defined as BCR-ABL transcript levels (expressed as a percentage compared with the ABL control gene) ≤ 0.1% based on PCR at day 85.

    Measured: Up to 100 days after treatment start

Secondary outcomes (14)

  1. Rate of Complete Remission (with and without complete count recovery, CR/CRi)

    Complete response rate is measured by the number of participants achieving complete remission (CR) or complete remission with incomplete platelet recovery (CRi) rate. CR is defined as having <5% marrow aspirate blasts, ANC >1,000/mcL, platelets > 100,000/mcL, no blasts in peripheral blood, and C1 extramedullary disease status. CRi is the same as CR but platelet count may be <= 100,000/mcL and/or ANC <=1,000/mcL.

    Measured: Up to 100 days after treatment start

  2. Disease-free Survival

    Measured from the date the participant first achieves CR or CRi until relapse from CR/CRi or death from any cause. Observations will be censored on the day of last contact for participants last known to be alive in CR/CRi.

    Measured: Up to 5 years.

  3. Overall Survival

    From the day of Step 1 registration on study until death from any cause with observations censored on the day of last contact for participants last known to be alive.

    Measured: Up to 5 years

  4. Incidence of Adverse Events

    Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported by given type of adverse event. Adverse Events are reported using CTCAE v 5.0.

    Measured: Up to 5 years

  5. Rate of Measurable Residual Disease Remission by Flow Cytometry (MRD Flow)

    Measurable residual disease (MRD) remission is defined as undetectable MRD levels by flow cytometry.

    Measured: Up to 100 days after treatment start

  6. Major molecular remission and measurable residual disease remission by flow cytometry

    Comparison of rates of major molecular remission by polymerase chain reaction (MMR) and measurable residual disease remission by flow cytometry (MRD Flow).

    Measured: Up to 100 days after treatment start

  7. Relapse from Major Molecular Remission (MMR)

    Cumulative incidence of relapse from MMR, defined as BCR-ABL transcript levels (expressed as a percentage compared with the ABL control gene) > 0.1% based on PCR.

    Measured: Up to 5 years

  8. Molecular Response 4.0 (MR4.0) Rate at Day 85

    MR4.0 is defined as a 4.0-log reduction, relative to baseline, of the BCR-ABL/ABL ratio based on PCR. This response is equivalent to a value of <= 0.01% when reported on the International Scale.

    Measured: Up to 100 days after treatment start

  9. Molecular Response 4.5 Rate at Day 85

    MR4.5 is defined as a 4.5-log reduction, relative to baseline, of the BCR-ABL/ABL ratio based on PCR. This response is equivalent to a value of <= 0.0032% when reported on the International Scale.

    Measured: Up to 100 days after treatment start

  10. Rate of Complete Remission with Undetectable MRD by Flow Cytometry

    Number of participants meeting criteria for complete remission (CR) and measurable residual disease flow remission (MRD Flow).

    Measured: Up to 5 years

  11. Duration of Major Molecular Remission by PCR

    Measured from the date the participant first achieves MMR until relapse from MMR or death from any cause. Observations will be censored on the day of last contact for participants last known to be alive in MMR.

    Measured: Up to 5 years

  12. Duration of MR4.0 by PCR

    Measured from the date the participant first achieves MR4.0 until relapse from MR4.0 or death from any cause. Observations will be censored on the day of last contact for participants last known to be alive in MR4.0.

    Measured: Up to 5 years

  13. Time to Treatment Failure

    From the day of Step 1 registration on study until treatment failure, or death due to any cause. Observations will be censored on the day of last contact for participants last known to be alive and failure free.

    Measured: Up to 5 years

  14. Event-free Survival

    From the day of Step 1 registration on study until failure to achieve CR/CRi following induction or re-induction, relapse from CR/CRi, or death due to any cause. Observations will be censored on the day of last contact for participants last known to be alive in CR/CRi.

    Measured: Up to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study start13 Apr 2026
  3. Primary completionMay 2029 (estimated)
  4. Study completionJul 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06773936
Sponsor's protocol ID
21CTP.LEUK01
Other IDs
CABL001AUS11R
Status last verified
Aug 2026
First submitted
8 Jan 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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