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

Study acronym: ALL2418
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Nov 2022 to Jul 15, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Nov 2022 to Oct 2026
    • Site details revised at 30 of 30 sites
    v6
  2. Primary completion date: Oct 2021 to Nov 2022
    • Study sites: 18 to 30
    v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Nov 2022 to Oct 2021
    • Start date changed from estimate of Dec 1, 2018 to Oct 30, 2019
    • Study sites: 0 to 18
    v4
  4. Start date: Oct 1, 2018 to Dec 1, 2018v3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03610438
Lead Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions
(from sponsor)		 Acute Lymphoid Leukemia
Related terms Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov