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.
Relapsed or refractory patients with T-lineage acute lymphoblastic leukemia or T-lymphoblastic lymphoma
18 years old or older
Bone marrow or peripheral blood involvement with ≥5% lymphoblasts or measurable residual disease with >10-4 level detected by multiparameter flow cytometry or next-generation sequencing (NGS)-based measurable residual disease (ClonoSEQ, Adaptive Technologies). Patients with isolated extramedullary disease that is measurable by computed tomography (CT) scan are also eligible.
Eastern Cooperative Oncology Group performance status 0-2.
Active central nervous system (CNS) leukemia
Active or chronic hepatitis B or C infection as evidenced by hepatitis B surface antigen and anti-hepatitis C antibody positivity, respectively, or known seropositivity for human immunodeficiency virus (HIV). Patients with HIV but an undetectable viral load are eligible for enrollment.
Major surgery within <2 weeks before randomization.
Unstable or severe uncontrolled medical condition (eg, unstable cardiac function or unstable pulmonary condition.
Single group
LP-118
DrugLP-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
DrugPonatinib is used to treat certain types of chronic myeloid leukemia (CML; a type of cancer of the white blood cells).
Vincristine
DrugVincristine 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
DrugDexamethasone 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
DrugMethotrexate is a drug used to treat cancer of the blood, bone, lung, breast, head, and neck. It can also treat rheumatoid arthritis and psoriasis.
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.
Complete Clinical Remission at Days 28 and 56
Complete clinical remission at days 28 and 56 for study participants defined as the disappearance of leukemia as indicated by \<5% marrow blasts and the absence of peripheral blasts, with recovery of hematopoiesis defined by ANC ≥1000/μL and platelets ≥100,000/μL.
Complete clinical remission with incomplete count recovery (CRi) at Days 28 and 56
Complete clinical remission with incomplete count recovery (CRi) at day 28 and 56 for study participants treated at the recommended phase 2 (RP2D) dose level, defined as complete clinical remission except with ANC\< 1000/μL and/or platelets \<100,000/μL
Complete Clinical Remission (CR) with Measurable Residual Disease (MRD)
Complete clinical remission with measurable residual disease (MRD) negativity at day 28 and 56 for participants treated at the recommended phase 2 (RP2D) dose level.
Complete clinical remission with incomplete count recovery (CRi) with Measurable Residual Disease (MRD)
CRi with MRD negativity at days 28 and 56, defined by absence of detectable disease by flow cytometry (sensitivity of 0.01%), and V(D)J next-generation sequencing-based MRD assessment (sensitivity of 0.0001%)
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