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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Inotuzumab Ozogamicin with Standard Chemotherapy Regimen for the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given with 3 and 4 drug standard chemotherapy regimen in treating patients with B-cell acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Chemotherapy drugs, such as daunorubicin, vincristine, cytarabine, methotrexate, and pegaspargase, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone lower the bodys immune response and are used with other drugs in the treatment of some types of cancer. Giving inotuzumab ozogamicin with standard chemotherapy may work better in treating patients with B-cell acute lymphoblastic leukemia compared to inotuzumab ozogamicin alone.
Leukemia, Phase I
Phase I
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics
Daunorubicin (Daunomycin), Inotuzumab Ozogamicin, Pegaspargase (PEG-ASP), Prednisone, Vincristine
Oluwole, Olalekan
Vanderbilt University


16 Years
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

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Left ventricular ejection fraction > 50% measured by echocardiogram or multigated acquisition scan (MUGA)

Either relapsed following remission after initial induction therapy or refractory to induction therapy

Serum creatinine / creatinine clearance = 50 ml/min by Cockcroft-Gault formula

Bilirubin =
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =
Alkaline phosphatase =
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 gastrointestinal (GI) disease, or inability to swallow medications

Philadelphia chromosome positive B-cell acute lymphoblastic leukemia (ALL)

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