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

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07614022
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Philadelphia Positive Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LP-118 — DRUG
    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

Study Details

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).

Key Dates

Start date
Oct 31, 2026
Status verified
May 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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). ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Atrium Health Levine CancerCharlotteNorth Carolina28204
Katarzyna Wydrzynska-Gruner, RN
[email protected]
704-355-2000
Thomas Knight, MD (SUB_INVESTIGATOR)
Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Dianna Auman, RN
[email protected]
336-716-1122
Madelyn Burkart, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Atrium Health Levine Cancer· Charlotte, NCAtrium Health Wake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NC

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