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Study of LP-118 for Newly-Diagnosed Philadelphia Positive ALL

This study is looking at a drug called LP-118 for adults newly diagnosed with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Ph+ ALL is a type of blood cancer with a specific genetic change. LP-118 will be given along with the standard treatments: ponatinib, dexamethasone, methotrexate, and blinatumomab. The main goal is to find the safest and most effective dose of LP-118 when combined with these standard therapies. To join, you must be at least 18 years old, have newly diagnosed CD19-positive Ph+ ALL, and be able to understand and sign a consent form. The study aims to enroll 26 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 26 participants. It will test different doses of LP-118 (50mg, 100mg, 200mg, or 300mg) in combination with standard treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main assessments for dose finding will occur over approximately 21 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07614022

A Study of LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, BCR::ABL1-Positive Acute Lymphoblastic Leukemia (ALL)

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~26 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:LP-118

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Estimation of the Maximum Tolerated Dose (MTD) for LP-118 (Dose Escalation)
Measured over The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days).
+1 more outcome measured

Conditions

Philadelphia Positive Acute Lymphoblastic Leukemia

Explore related trials

Acute Lymphoblastic LeukemiaCD19 Genet(9;22)(q34.1;q11.2)

NCT07614022

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atrium Health Levine Cancer

    Charlotte, North Carolinastudy coordinator listed

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolinastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Madelyn Burkart, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Dianna Auman, RN
[email protected]
336-716-1122
Email the study team

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Eligibility criteria

Inclusion

Ability to understand and willingness to sign an IRB-approved informed consent.
Age ≥ 18 years at the time of consent.
ECOG Performance Status (PS) ≤ 2.
Histological or cytological confirmation of newly diagnosed CD19-positive Philadelphia-chromosome/BCR::ABL1-positive ALL.
Creatinine clearance: ≥60 mL/min, determined by the Cockroft-Gault formula, or measured by a 24-hour urine collection.
Bilirubin ≤ 1.5 × upper limit of normal (ULN) - Unless liver abnormalities considered due to Gilbert's syndrome or of non-hepatic origin i.e., leukemic involvement. For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.
Aspartate aminotransferase (AST) - Unless liver abnormalities considered due to Gilbert's syndrome or of non-hepatic origin i.e., leukemic involvement. For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.
Alanine aminotransferase (ALT) - Unless liver abnormalities considered due to Gilbert's syndrome or of non-hepatic origin i.e., leukemic involvement. For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.
Individuals of childbearing potential (ICBP) must have a negative serum pregnancy test. NOTE: Individuals who may become pregnant are considered to have childbearing potential unless they are surgically infertile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause).
ICBP must be willing to use two forms of contraception, one of which must be a barrier method and the other must be a highly effective contraceptive method from the time of informed consent until 6 months after study treatment discontinuation. Male participants with female partners of reproductive potential will need to agree to use contraception methods described above during study treatment and for at least 6 months after completion of all study treatment.
Male participants must agree to refrain from sperm donation during study treatment and for at least 6 months after completion of all study treatment.
Ability to ingest oral medications without a malabsorption condition, known dysphagia, short-gut syndrome, gastroparesis, or other conditions that may limit the ingestion or gastrointestinal absorption, distribution, metabolism and excretion of drugs administered orally, per the enrolling investigator.

Exclusion

Any prior treatment for ALL except for a single dose of intrathecal (IT) chemotherapy, corticosteroids, hydroxyurea, a single dose of vincristine, cytarabine, leukapheresis, and/or a BCR::ABL1-targeted tyrosine kinase inhibitor. Permitted prior treatment is limited to a duration of no longer than 14 days. Permitted prior treatment must be stopped at least 24 hours prior to starting study therapy.
Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least 6 months after the last administration of all study treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study. Pregnant participants are excluded from this study because ponatinib, blinatumomab, and methotrexate have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ponatinib, blinatumomab, and methotrexate breastfeeding should be discontinued if the patient is treated with ponatinib, blinatumomab, and methotrexate.
Active second malignancy except for localized prostate cancer, basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the skin or cervix.
Unstable or severe uncontrolled medical condition in the opinion of the enrolling investigator (e.g., unstable cardiac function or unstable pulmonary condition; uncontrolled infection).
Participants with known history of hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) are eligible if no evidence of active viral replication by blood testing (i.e. negative viral loads). HIV positive participants must be on active anti-retroviral therapy and willing to continue therapy during study treatment.
Uncontrolled cardiac disease as determined by the enrolling investigator.
Major surgery, as determined by the enrolling investigator, within 2 weeks before enrollment.

What this trial measures

  • Estimation of the Maximum Tolerated Dose (MTD) for LP-118 (Dose Escalation)The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days).

    Binary variable indicating if a Dose Limiting Toxicity (DLT) occurred.

  • Identification of the Recommended Phase 2 Dose (RP2D) LP-118 (Dose Expansion)The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days).

    Binary variable indicating if a Dose Limiting Toxicity (DLT) occurred.