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Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

Study acronym: Interfant-21
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Trial sites expanded: 115 → 124 locationsv9
  2. Minor Trial sites expanded: 112 → 115 locationsv8
  3. Notable Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 90 to 112
    v7
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 76 to 90
    • Eligibility criteria shortened, about 94 words
    v6
  5. Minor Study sites: 59 to 76
    • Collaborators reordered
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Study sites: 30 to 59v4
  2. Minor Study sites: 23 to 30v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 23
    • Start date changed from estimate of Sep 2022 to Dec 15, 2022
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.
Trial Details
NCT Number NCT05327894
Lead Sponsor Princess Maxima Center for Pediatric Oncology
Collaborators: University of Milano Bicocca, Amgen Europe B.V
Conditions
(from sponsor)
Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
Related terms Leukemia, Biphenotypic, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov