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A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorAmgen
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Dec 5, 2028 → Mar 6, 2031
See other at-risk trials from Amgen

Record History

  1. Primary completion pushed from Dec 5, 2028 to Mar 6, 2031 Primary endpoints: details revised at 1 of 7 entries · Completion pushed from Jun 18, 2030 to Sep 16, 2032 · Secondary endpoints: details revised at 8 of 18 entries · 1 more Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 7 entries
    • Completion pushed from Jun 18, 2030 to Sep 16, 2032
    • Secondary endpoints: details revised at 8 of 18 entries
    • Eligibility criteria shortened, about 3 words
  2. Trial status changed: Recruiting → Active, Not Recruiting Study sites: 4 to 5v7 Show 1 more changeShow less
    • Study sites: 4 to 5
  3. Study sites: 3 to 4v6
  4. Study sites: 2 to 3v5
  5. Study sites: 1 to 2v4
Show 2 earlier versionsHide 2 earlier versions
  1. Collaborators expanded, about 2 wordsv3 See this version in full on ClinicalTrials.gov ↗
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 21, 2025 to Dec 8, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 21, 2025 to Dec 8, 2025
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.
Trial Details
NCT Number NCT07134088
Lead Sponsor Amgen
Collaborators: BeOne Medicines
Conditions Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia, Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia
Enrollment 104 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov