A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients

    Not Recruiting
  • End date
    Sep 22, 2023
  • participants needed
  • sponsor
Updated on 5 March 2022
lymphoid leukemia
lymphoblastic lymphoma
induction chemotherapy
kinase inhibitor
serum bilirubin level
blast cells
refractory acute lymphoblastic leukemia


This study will explore 2 different doses of inotuzumab ozogamicin including the dose that is approved and a lower dose. The main purpose of this study is to evaluate whether a dose of inotuzumab ozogamicin, lower than the approved dose, could be recommended for adult patient with relapsed or refractory ALL who may be at higher risk for severe liver problems after inotuzumab ozogamicin treatment and stem cell transplant (a potentially curative therapy that can replace cancer cells with healthy cells). Efficacy and safety of the 2 doses will be evaluated.

Condition Leukemia, Precursor b-Cell Lymphoblastic Leukemia-Lymphoma, ACUTE LYMPHOBLASTIC LEUKEMIA
Treatment inotuzumab ozogamicin-dose level 2, Inotuzumab ozogamicin-dose level 1
Clinical Study IdentifierNCT03677596
Last Modified on5 March 2022

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