A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06207123
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acute Leukemia
  • Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma

Eligibility Criteria

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

Interventions

  • LP-118 — DRUG
    LP-118 is an experimental anti-cancer drug that is currently being studied in clinical trials for multiple types of hematological cancers and solid tumors.
  • Ponatinib — DRUG
    Ponatinib is used to treat certain types of chronic myeloid leukemia (CML; a type of cancer of the white blood cells).
  • Vincristine — DRUG
    Vincristine is a chemotherapy medication used to treat various types of cancer, including leukemia, lymphoma, neuroblastoma, and Wilms tumor. Vincristine belongs to the category of vinca alkaloids, a class of drugs that function by impeding the proper division of cancer cells.
  • Dexamethasone — DRUG
    Dexamethasone is used to treat cancer, to decrease inflammation and sometimes used before and after chemotherapy to prevent or treat nausea and/or vomiting. It is given in the vein (IV) or orally (by mouth)
  • Methotrexate — DRUG
    Methotrexate is a drug used to treat cancer of the blood, bone, lung, breast, head, and neck. It can also treat rheumatoid arthritis and psoriasis.

Study Details

The purpose of this study is to learn more about LP-118 (an experimental drug) and its side effects and decide on acceptable doses. The purpose of this study is to determine if LP-118 can be given safely with another medicine called ponatinib, that is FDA-approved for the treatment of acute lymphoblastic leukemia.

Key Dates

Start date
Sep 13, 2024
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All Participants (Single Arm)
    All study participants will receive LP-118 and ponatinib. The initial dose of LP-118 to be tested is 100 mg, and initial dose of ponatinib to be tested is 30 mg. Higher doses of LP-118 will only be tested if the study doctor feels it is safe to do so. A member of the study team will let study participants know which doses they are assigned. Study drugs will be given in 21-day cycles. There will be 7 study visits in cycle 1 (on Days 1, 5, 6, 7, 15, 22, and 28). LP-118 and ponatinib will be taken at home every day. Dexamethasone will be taken between days 1-7 and days 15-22. For Cycles 2-12, study participants will have 5 study visits per cycle (on Days 1, 8, 15, 22, and 28). On all days, study participants will take LP-118 and ponatinib at home. Participants in this group will also receive standard of care vincristine, dexamethasone, and methotrexate during study cycles.

Primary Outcome Measure

Recommended Phase II Dose To demonstrate safety and to identify the recommended phase II dose for combination of LP-118, ponatinib, vincristine and dexamethasone [ Time Frame: 36 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60615
Caner Saygin, MD
[email protected]
773-834-8982
University of Rochester Medical Center, Wilmot Cancer CenterRochesterNew York14642
Kristen O'Dwyer, MD
[email protected]
585-275-5863
Wilmot Cancer Center Clinical Trials Office
[email protected]
585-275-5863
Kristen O'Dwyer, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Chicago Medicine Comprehensive Cancer Center· Chicago, ILUniversity of Rochester Medical Center, Wilmot Cancer Center· Rochester, NY

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