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

  • STATUS
    Recruiting
  • End date
    Dec 11, 2023
  • participants needed
    102
  • sponsor
    Pfizer
Updated on 24 July 2021
cancer
lymphoid leukemia
lymphoma
lymphoblastic lymphoma
induction chemotherapy
kinase inhibitor
serum bilirubin level
blast cells
lymphoblasts
inotuzumab
refractory acute lymphoblastic leukemia

Summary

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.

Details
Condition childhood ALL, leukemia, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia (Pediatric), Lymphocytic Leukemia, Acute, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, leukemias, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all)
Treatment inotuzumab ozogamicin-dose level 2, Inotuzumab ozogamicin-dose level 1
Clinical Study IdentifierNCT03677596
SponsorPfizer
Last Modified on24 July 2021

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