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Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)

Study acronym: MOSAIC
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Secondary endpoints: 10 to 6v8
  3. Eligibility criteria expanded, about 33 words
    • Study sites revised (21)
    v7
  4. Trial status: Active, Not Recruiting to Recruitingv6 Show 7 more changesShow less
    • Enrollment target: 11 to 214
    • Primary completion date: Aug 13, 2021 to Apr 2027
    • Study sites: 11 to 21
    • Interventions: MAGMA-trial: conventional chemotherapy (AraC+DNR)+Midostaurin (Drug), MAGMA-trial:GO associated with conventional chemotherapy… to MAGMA-trial: conventional chemotherapy (AraC+DNR)+Midostaurin (Drug), MAGMA-trial:GO associated with conventional chemotherapy…
    • Eligibility criteria expanded, about 84 words
    • Secondary endpoints: details revised at 5 of 10 entries
    • Study description expanded, about 1 word
  5. Enrollment target: estimated 214 to confirmed 11
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of May 2021 to Aug 13, 2021
    • Site details revised at 11 of 11 sites
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 9 to 11v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2020 to Sep 4, 2020
    • Site details revised at 9 of 9 sites
    v3
  3. Interventions: MAGMA-GO (Drug), MAGMA-noGO (Drug), MAGNOLIA-GOPlacebo (Drug), MAGNOLIA-MidoGO (Drug), MODULE (Drug) to MAGMA-trial: conventional chemotherapy (AraC+DNR)+Midostaurin (Drug), MAGMA-trial:GO associated with conventional chemotherapy…
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 1 of 10 entries
    • Study description expanded, about 35 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase I/II clinical trial evaluates the safety and efficacy of the combined administration of midostaurin and gemtuzumab ozogamicin in the frame of first-line standard chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients displaying a cytogenetic aberration or fusion transcript in the core-binding factor (CBF) genes or FMS-like tyrosine Kinase 3 (FLT3) mutation.
Trial Details
NCT Number NCT04385290
Lead Sponsor Technische Universität Dresden
Collaborators: Novartis Pharmaceuticals, Pfizer
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 214 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov