Phase
Condition
Leukemia
Lymphoproliferative Disorders
Lymphocytic Leukemia, Acute
Treatment
LP-118
Dexamethasone
Ponatinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Relapsed or refractory patients with T-lineage acute lymphoblastic leukemia orT-lymphoblastic lymphoma
18 years old or older
Bone marrow or peripheral blood involvement with ≥5% lymphoblasts or measurableresidual disease with >10-4 level detected by multiparameter flow cytometry ornext-generation sequencing (NGS)-based measurable residual disease (ClonoSEQ,Adaptive Technologies). Patients with isolated extramedullary disease that ismeasurable by computed tomography (CT) scan are also eligible.
Eastern Cooperative Oncology Group performance status 0-2.
Adequate organ function as defined by all of the following:
Creatinine clearance ≥50 mL/min, determined by the Cockroft-Gault formula, ormeasured by a 24-hour urine collection.
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limitof normal (ULN) and bilirubin ≤1.5 x ULN (unless considered due to Gilbert'ssyndrome or of non-hepatic origin i.e,, leukemic involvement). For patientswith Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin levelwill be required.
Participants must be at least 2 weeks from major surgery or radiation therapy. Awash-out period of 4 half-lives is required for patients who participated in otherinvestigational trials. These patients must have recovered from clinicallysignificant toxicities related to these prior treatments.
Participants must voluntarily sign and date an informed consent, approved by anIndependent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to theinitiation of any screening or study-specific procedures.
Females of childbearing potential will use effective contraception during protocoltreatment and for at least 8 months after the last dose. Males with female partnersof reproductive potential will use effective contraception during protocol treatmentand for at least 5 months after the last dose. A patient is of childbearingpotential if, in the opinion of the treating investigator, he/she is biologicallycapable of having children and is sexually active. Female patients who are not ofchildbearing potential (ie, meet at least one of the following criteria): a. Have undergone hysterectomy or bilateral oophorectomy; or have medicallyconfirmed ovarian failure; or are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternativepathological or physiological cause).
Participants who are willing and able to comply with scheduled visits, treatmentplan, laboratory tests, and other study procedures.
Exclusion
Exclusion Criteria:
Active central nervous system (CNS) leukemia
Active or chronic hepatitis B or C infection as evidenced by hepatitis B surfaceantigen and anti-hepatitis C antibody positivity, respectively, or knownseropositivity for human immunodeficiency virus (HIV). Patients with HIV but anundetectable viral load are eligible for enrollment.
Major surgery within <2 weeks before randomization.
Unstable or severe uncontrolled medical condition (eg, unstable cardiac function orunstable pulmonary condition.
Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situof the cervix, or localized prostate cancer that has been definitely treated withradiation or surgery. Patients with previous malignancies are eligible provided thatthey have been disease free for ≥2 years or are not currently requiring treatment.
Uncontrolled cardiac disease.
Pregnant females; breastfeeding females; males with female partners of reproductivepotential and females of childbearing potential not using highly effectivecontraception or not agreeing to continue highly effective contraception for aminimum of 5 months after the last dose of investigational product if male and 8months after the last dose of investigational product if female.
Participation in other investigational studies during active treatment phase.
Other severe acute, chronic medical, psychiatric condition, or laboratoryabnormality that may increase the risk associated with study participation orinvestigational product administration or may interfere with the interpretation ofstudy results and, in the judgment of the treating physician, would make the patientinappropriate for entry into this study.
Study Design
Study Description
Connect with a study center
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois 60615
United StatesSite Not Available
University of Chicago Medicine Comprehensive Cancer Center
Chicago 4887398, Illinois 4896861 60615
United StatesActive - Recruiting
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