Full Title
A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy (AALL1732) (CIRB)Purpose
The overall goal of this study is to see if adding inotuzumab ozogamicin to standard chemotherapy maintains or improves treatment effectiveness in young patients with high-risk B cell acute lymphoblastic leukemia (B-ALL). Inotuzumab ozogamicin contains an antibody (inotuzumab) linked to a type of chemotherapy (calicheamicin). Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them.
The first part of the study includes the first two phases of therapy: induction and consolidation. During this part, researchers will collect information on each patient’s leukemia, as well as the effects of their initial treatment, in order to classify patients into treatment groups for the next phase of the study. During the second part of this study, patients will receive the remainder of their chemotherapy cycles, and some of them will be randomly assigned to also receive inotuzumab ozogamicin.
Finally, this study will be the first to see how patients with disseminated B-cell lymphoblastic leukemia (B-LLy), or mixed phenotype acute leukemia (MPAL) do when treated with the standard chemotherapy used for B-ALL (without inotuzumab ozogamicin).
Who Can Join
To take part in this study, patients must meet several requirements, including:
- Participants must have newly diagnosed high-risk B-ALL, B-LLy, or MPAL.
- Patients must be older than age 1 and younger than 25.
Contact
For more information about this study and to ask about eligibility, please contact 1-833-MSK-KIDS.