A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults with Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia

Protocol No
ALLIANCE-A042001
Phase
II
Summary

This study is being done to answer the following question: Can we improve the chance of your leukemia going away (remission) and lower the chance of your leukemia coming back (relapsing) by adding an investigational drug called inotuzumab ozogamicin (hereafter, inotuzumab) to lower doses of the usual chemotherapy for acute lymphoblastic leukemia?
We are doing this study because we want to find out if this approach is better or worse than the
usual approach for your acute lymphoblastic leukemia. The usual approach is defined as care
most people get for acute lymphoblastic leukemia.

Description
This study is being done to answer the following question: Can we improve the chance of your leukemia going away (remission) and lower the chance of your leukemia coming back (relapsing) by adding an investigational drug called inotuzumab ozogamicin (hereafter, inotuzumab) to lower doses of the usual chemotherapy for acute lymphoblastic leukemia?
We are doing this study because we want to find out if this approach is better or worse than the
usual approach for your acute lymphoblastic leukemia. The usual approach is defined as care
most people get for acute lymphoblastic leukemia.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL