Inotuzumab as Post-Trasplantation Therapy for Adult High-risk B-cell Precursor Acute Lymphoblastic Leukemia

Study acronym: INOPOSALO
StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

  1. Study First Submitted
The goal of this clinical trial is to learn if Inotuzumab Ozogamicin works to prevent relapses after transplantation in adult high-risk B-cell precursor acute lymphoblastic leukemia treated with the PETHEMA ALL-2025 protocol. The main questions it aims to answer are: * Do patients receiving Inotuzumab ozogamicin post-transplantation suffer less relapses than those patients not receiving this therapy (control group) within the ALL-2025 protocol? * Do patients receiving Inotuzumab ozogamicin show more adverse events and severe adverse events related with this treatment than those patients no receiving this intervention (control group)? Researchers will compare the relapse rate between patients receiving Inotuzumab Ozogamicin post-transplantation and patients not receiving Inotuzumab Ozogamicin post-trasnplantation within the ALL-2025 protocol. Participants will receive 3 cycles of Inotuzumab Ozogamicin therapy. Treatment will be initiated from day +70 post-transplantation and a minimum interval of 30 days between consecutive administrations.
Trial Details
NCT Number NCT07862946
Lead Sponsor PETHEMA Foundation
Conditions
(from sponsor)		 Acute Lymphobkastic Leukemia, Adult
Related terms Recurrence
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov