Recruiting
Phase 1

LP-118 with Ponatinib, Dexamethasone, Methotrexate, Blinatumomab

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07614022

Conditions

Philadelphia Positive Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LP-118

Study Details

Brief summary:

The purpose of this research study is to see if a drug called LP-118 is safe and effective for treating adults with Philadelphia chromosome-positive (Ph+) B cell acute lymphoblastic leukemia (ALL), when given with ponatinib, dexamethasone, methotrexate and blinatumomab (the standard treatment for this type of cancer).

Conditions

Philadelphia Positive Acute Lymphoblastic Leukemia

Study ID

NCT07614022

Start date

Dec, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

26 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Combination of LP-118, ponatinib, dexamethasone, blinatumomab and methotrexate

LP-118 will be given as tablets of 10mg or 100mg during the induction II course only in combination with ponatinib, dexamethasone, methotrexate and blinatumomab. . Ponatinib, dexamethasone and methotrexate dosing will remain fixed, whereas LP-118 dosing will be dependent on the dose level to which a participant is assigned.

Interventions

LP-118

s LP-118 dosing will be dependent on the dose level to which a participant is assigned:

  • 50mg PO
  • 100mg PO
  • 200mg PO
  • 300mg PO

Primary outcome measure

  • Estimation of the Maximum Tolerated Dose (MTD) for LP-118 (Dose Escalation) [ Time Frame: The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days). ]
  • Identification of the Recommended Phase 2 Dose (RP2D) LP-118 (Dose Expansion) [ Time Frame: The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days). ]

Central Contacts and Locations

Central contacts

Dianna Auman, RN

336-716-1122Dianna.Roesler@Advocatehealth.org

Locations

Atrium Health Levine Cancer

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Katarzyna Wydrzynska-Gruner, RN

704-355-2000katarzyna.wydrzynskagruner@advocatehealth.org

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Dianna Auman, RN

336-716-1122Dianna.Roesler@Advocatehealth.org

Principal Investigator:

Madelyn Burkart, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • Leukemia
  • Philadelphia-Chromosome positive
  • cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.