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A Phase I Study of LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, BCR::ABL1-Positive ALL

NCT07614022 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-05-29

No results posted yet for this study

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

Interventions

DRUG

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

Sponsors & Collaborators

  • Newave Pharmaceutical Inc

    collaborator INDUSTRY

  • Atrium Health Wake Forest Baptist

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Madelyn Burkart, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2030-03-31
Completion
2030-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614022 on ClinicalTrials.gov