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Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"

Study acronym: OVERALL
StatusTerminated
PhasePhase 2
Started
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Record History

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  1. Trial terminated Sponsor's reason: Following the recommendation of the Data Monitoring Committee (DMC), based on the results of the interim analysis, the Sponsor has decided to terminate the study prematurely Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Final enrollment: 49 participants (planned 124)
    • Primary completion date changed from estimate of Dec 31, 2025 to Apr 21, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Site details revised at 19 of 19 sites
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Jun 30, 2023 to Dec 31, 2025
    • Start date changed from estimate of Jun 30, 2021 to Oct 5, 2021
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    • Study sites revised (19)
    • Study title revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients (62 in each study group).
Trial Details
NCT Number NCT04920968
Lead Sponsor Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators: KCRI
Conditions
(from sponsor)		 CD20-positive Acute Lymphoblastic Leukemia
Enrollment 49 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov