StudyFinder
Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL
Recruiting
16 years to 60 years old
Inclusion Criteria:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Diagnosed with CD-22 positive* B-cell Acute Lymphoblastic Leukemia or B-cell Lymphoblastic Lymphoma (Philadelphia chromosome negative) * For the purposes of this study, CD-22 positive will be defined based on the analysis completed for diagnostic purposes.
• Male or female, aged 16-60 years
• ECOG performance status of 0-2
• Left ventricular ejection fraction ≥ 50% measured by echocardiogram or MUGA
• Either relapsed following remission after initial induction therapy or refractory to induction therapy
• Adequate organ function, including serum creatinine ≤ 1.6 mg/dL OR creatinine clearance >50 ml/min by Cockgroft-Gault formula, bilirubin ≤ 1.5 mg/dL (except in patients with Gilbert's disease), AST, ALT and alkaline phosphatase ≤ 3 x upper limit of normal (elevation exceeding this threshold of either AST OR ALT would not meet eligibility)
• For females of reproductive potential: negative pregnancy test
• For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 1 year after the end of study treatment
• Agreement to adhere to Lifestyle Considerations throughout study duration and for 1 year following last study treatment.
Exclusion Criteria:
• Past receipt of a total of ≥ 300 mg/m^2 doxorubicin equivalents (600 mg/m^2 daunorubicin, 60 mg/m^2 idarubicin, 75 mg/m^2 mitoxantrone)
• Current or past history of pancreatitis
• QT interval on electrocardiogram (ECG) > 0.45 by Framingham formula
• Known congestive heart failure
• Known allergy to asparaginase (only an exclusion criteria for participants enrolling in part 2)
• Presence of central nervous system (CNS) disease
• Pregnancy or lactation
• Chronic liver disease including chronic active hepatitis and/or cirrhosis
• Active Hepatitis B virus (HBV) by core antibody, surface antigen (HBsAg) or viral load
• Active Hepatitis C virus (HCV) (positive antibody test confirmed by viral load if antibody test is positive)
• Known history of infection with Human Immunodeficiency Virus (HIV)
• Active or uncontrolled infections
• Abnormal baseline hepatic ultrasound (including Dopplers)
• Prior allogeneic stem cell transplant
• Prior use of inotuzumab ozogamicin
• Known diagnosis of hemochromatosis with iron overload
• Treatment with steroids or hydroxyurea for more than 7 days with each within the 2 weeks prior to registration -that is, each is allowed for up to 7 days
• Gastrointestinal tract disease causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease, or inability to swallow medications.
• Philadelphia chromosome positive B-cell ALL
Drug: Inotuzumab ozogamicin, Drug: Prednisone Pill, Drug: Daunorubicin, Drug: Vincristine, Drug: Cytarabine, Drug: Methotrexate, Drug: Pegaspargase
B-cell Acute Lymphoblastic Leukemia
Amy Smith, BS - AJB6BB@hscmail.mcc.virginia.edu
Maher, Keri
Phase 1
HM20020385
NCT03962465
See this study on ClinicalTrials.gov