Clinical Trial

Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia

Study acronym: ALL2418
Active, Not Recruiting Phase 2
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Summary
This is a multi-center, phase 2A exploratory study of feasibility and effectiveness of Inotuzumab Ozagomicin in adult patients with Acute Lymphoid Leukemia (ALL) with positive minimal residual disease before any hematopoietic stem cell transplantation. The study is divided in two cohorts; cohort 1 will enroll 38 Ph+ patients, cohort 2 will enroll 38 Ph- patients, as defined with statistical analysis. The two cohorts will have the same treatment, with the exception of short term and long term maintenance.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2018-07-31; most recent amendment 2026-07-15.
Status change: Recruiting → Active, Not Recruiting 2026-07-15
Status change: Not Yet Recruiting → Recruiting 2020-06-03
Trial Details
NCT Number NCT03610438
Lead Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions Acute Lymphoid Leukemia
Enrollment 76 participants
Start Date 2019-10-30
Primary Completion 2026-07-15 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-16