A Phase I/II Study to Investigate the Combination of LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory T-ALL/LBL
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.
Detailed description
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. This study will investigate the combination of LP-118 and ponatinib at different dose levels to find the best doses that can be safely given to patients. This means that enrolled subjects will receive progressive increasing or decreasing doses of these drugs until the maximally tolerated dose is determined. All participants will also receive a standard of care chemotherapy combination consisting of the FDA approved drugs vincristine, dexamethasone and intrathecal (injection into the spinal canal, also called "spinal tap") methotrexate. This combination is standard of care for relapsed T-ALL/LBL.
Arms & 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.
Outcome measures
Primary
Recommended Phase II Dose To demonstrate safety and to identify the recommended phase II dose for combination of LP-118, ponatinib, vincristine and dexamethasone
Recommended phase II dose for combination of LP-118, ponatinib, vincristine and dexamethasone as assessed by rate of dose-limiting toxicities among study participants.
Time frame: 36 weeks
Secondary
Complete Clinical Remission at Days 28 and 56
Time frame: 36 weeks
Complete clinical remission with incomplete count recovery (CRi) at Days 28 and 56
Time frame: 36 weeks
Complete Clinical Remission (CR) with Measurable Residual Disease (MRD)
Time frame: 36 weeks
Complete clinical remission with incomplete count recovery (CRi) with Measurable Residual Disease (MRD)
Time frame: 36 weeks
Overall Survival
Time frame: 36 weeks
Progression-Free Survival
Time frame: 36 weeks
Eligibility criteria
Study locations (2)
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60615
University of Rochester Medical Center, Wilmot Cancer Center
Rochester, New York, 14642