Study on LP-118, Ponatinib, Vincristine, and Dexamethasone for Treating Relapsed or Hard-to-Treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Sponsor: University of Chicago
ClinicalTrials ID:NCT06207123
This clinical trial is exploring a new drug, LP-118, in combination with ponatinib, vincristine, and dexamethasone to treat patients with acute lymphoblastic leukemia or lymphoblastic lymphoma that has returned or is not responding to treatment.
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Program Overview
The aim of this study is to learn more about a new drug called LP-118 and its side effects, and to find the best dose when used with ponatinib, a drug already approved for treating acute lymphoblastic leukemia. Researchers want to see if these drugs can be safely combined. Participants will also receive standard chemotherapy drugs, vincristine and dexamethasone, along with methotrexate given through a spinal tap, which is a common treatment for relapsed T-ALL/LBL.
Description
This study is testing a new drug, LP-118, to see how it works and what side effects it might have when used with ponatinib, a drug approved for acute lymphoblastic leukemia. The study will try different doses of LP-118 and ponatinib to find the safest and most effective amounts. Participants will also receive standard chemotherapy drugs, vincristine and dexamethasone, and methotrexate through a spinal tap, which is a common treatment for relapsed T-ALL/LBL. The goal is to find the best combination of these drugs to help patients whose leukemia or lymphoma has returned or is not responding to treatment.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older with relapsed or hard-to-treat T-lineage acute lymphoblastic leukemia or T-lymphoblastic lymphoma.
- Cancer must be present in the bone marrow or blood, or there must be measurable disease in other areas as shown by a CT scan.
- Must be in good general health with a performance status score of 0 to 2.
- Must have good organ function, including adequate kidney and liver function.
- Must be at least two weeks from major surgery or radiation therapy and have recovered from any side effects of previous treatments.
- Must agree to use effective birth control during the study and for a period after the last dose of the study drugs.
- Must be willing to follow the study schedule and procedures, including signing an informed consent form.
Exclusion Criteria
- Active leukemia in the central nervous system.
- Active or chronic hepatitis B or C infection, or known HIV infection unless the viral load is undetectable.
- Major surgery within two weeks before starting the study.
- Unstable or severe uncontrolled medical conditions, such as heart or lung problems.
- Another active cancer, except for certain skin cancers or localized prostate cancer that has been treated.
- Uncontrolled heart disease.
- Pregnant or breastfeeding women, or those not using effective birth control.
- Participation in other investigational studies during the active treatment phase.
- Any severe medical or psychiatric condition that could increase the risk of participating in the study or interfere with the study results.
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