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Site For 18-047, EA9152 Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell ALL

Site For 18-047, EA9152 Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell ALL
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03504644
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Inclusion Criteria:
Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy(≥ 5% marrow lymphoblasts, assessed by morphology and flow cytometry
ECOG performance status 0-2
Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
Adequate liver function with AST/ALT less than 3X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent
Exclusion Criteria:
Pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
Evidence of isolated extramedullary relapse (i.e., testicular or CNS)
Serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
Poorly controlled HIV, or CD4 < 400. HIV positive patients are allowed on this study if they have a CD4 count greater than or equal to 400, and are on a stable antiviral regimen
Patients with NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
Cancer
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Study Locations

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Location
Hershey, PA