RecruitingPhase 1Phase 2NCT06207123

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

A Phase I/II Study to Investigate the Combination of LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory T-ALL/LBL

Sponsor

University of Chicago

Enrollment

15 participants

Start Date

Sep 13, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Leukemia Lymphoblastic Lymphoma Lymphoblastic Leukemia

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug combination (LP-118, ponatinib, vincristine, and dexamethasone) for patients with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma that has come back or stopped responding to previous treatments. These are aggressive blood cancers that are hard to treat when they relapse. **You may be eligible if...** - You are 18 or older - You have T-ALL or T-lymphoblastic lymphoma that has relapsed or is not responding to treatment - Your cancer shows measurable disease in bone marrow, blood, or on imaging - You are in adequate general health **You may NOT be eligible if...** - You have had prior treatment with ponatinib or similar drugs - You have significant heart problems or uncontrolled infections - You have cancer that has spread to the brain in an uncontrolled way Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLP-118

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.

DRUGPonatinib

Ponatinib is used to treat certain types of chronic myeloid leukemia (CML; a type of cancer of the white blood cells).

DRUGVincristine

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.

DRUGDexamethasone

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)

DRUGMethotrexate

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.

Locations(2)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

University of Rochester Medical Center, Wilmot Cancer Center

Rochester, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06207123

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