The purpose of this research study is to see if a drug called LP-118 is safe and effective for treating adults with Philadelphia chromosome-positive (Ph+) B cell acute lymphoblastic leukemia (ALL), when given with ponatinib, dexamethasone, methotrexate and blinatumomab (the standard treatment for this type of cancer).
Ability to understand and willingness to sign an IRB-approved informed consent.
Age ≥ 18 years at the time of consent.
ECOG Performance Status (PS) ≤ 2.
Histological or cytological confirmation of newly diagnosed CD19-positive Philadelphia-chromosome/BCR::ABL1-positive ALL.
Any prior treatment for ALL except for a single dose of intrathecal (IT) chemotherapy, corticosteroids, hydroxyurea, a single dose of vincristine, cytarabine, leukapheresis, and/or a BCR::ABL1-targeted tyrosine kinase inhibitor. Permitted prior treatment is limited to a duration of no longer than 14 days. Permitted prior treatment must be stopped at least 24 hours prior to starting study therapy.
Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least 6 months after the last administration of all study treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study. Pregnant participants are excluded from this study because ponatinib, blinatumomab, and methotrexate have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ponatinib, blinatumomab, and methotrexate breastfeeding should be discontinued if the patient is treated with ponatinib, blinatumomab, and methotrexate.
Active second malignancy except for localized prostate cancer, basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the skin or cervix.
Unstable or severe uncontrolled medical condition in the opinion of the enrolling investigator (e.g., unstable cardiac function or unstable pulmonary condition; uncontrolled infection).
Sequential
LP-118
Drugs LP-118 dosing will be dependent on the dose level to which a participant is assigned: * 50mg PO * 100mg PO * 200mg PO * 300mg PO
Estimation of the Maximum Tolerated Dose (MTD) for LP-118 (Dose Escalation)
Binary variable indicating if a Dose Limiting Toxicity (DLT) occurred.
Identification of the Recommended Phase 2 Dose (RP2D) LP-118 (Dose Expansion)
Binary variable indicating if a Dose Limiting Toxicity (DLT) occurred.
Overall Survival (OS).
The time from treatment administration to death from any cause, or until last contact if the patient has not died
Relapsed-Free Survival (RFS).
Time from Complete Remission (CR) or Complete Remission with Incomplete Hematologic Recovery (CRi) to disease relapse or death (whichever occurs first) or otherwise censored at the date of the last disease assessment.
Event-Free Survival (EFS).
Time from start of therapy until failure to achieve CR/CRi, relapse, or death from any cause or otherwise censored at the date of the last disease assessment.
Overall Complete Molecular Response (CMR) rate.
Binary variable indicating if a CMR at any time while on study.
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Wake Forest University Health Sciences
Lead sponsor
Newave Pharmaceutical Inc
Collaborator
Atrium Health Wake Forest Baptist
Collaborator
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
