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Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Feb 2028 → Jun 2029
Enrollment reduced 30% 40 → 28 participants
See other at-risk trials from Goethe University

Record History

  1. Primary completion pushed from Feb 2028 to Jun 2029 Enrollment reduced: 40 → 28 participants · Completion pushed from Aug 2028 to Jun 2030 · Eligibility criteria shortened, about 99 words · 1 morev12 Show 4 more changesShow less
    • Enrollment reduced: 40 → 28 participants
    • Completion pushed from Aug 2028 to Jun 2030
    • Eligibility criteria shortened, about 99 words
    • Secondary endpoints: details revised at 4 of 14 entries

    See this version in full on ClinicalTrials.gov ↗

  2. Site contacts updated at 1 of 15 sitesv11
  3. Study sites: 14 to 15v10
  4. Re-verified, no change to tracked fieldsv9
  5. Study sites: 13 to 14v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 12 to 13v7
  2. Study sites: 11 to 12v6
  3. Study sites: 10 to 11v5
  4. Study sites: 8 to 10v4
  5. Study sites: 7 to 8v3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 7 · Start date changed from estimate of Oct 31, 2024 to Oct 22, 2024v2 Show 2 more changesShow less
    • Study sites: 1 to 7
    • Start date changed from estimate of Oct 31, 2024 to Oct 22, 2024
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 planned trial offers treatment cohorts for patients with full cytologic relapse (R/R ALL - Cohort 1), as well as for patients with molecular failure/relapse (MRD+ ALL - Cohort 2). Basically, the study aims to develop data for optimization of first-line therapy of T-ALL, either by modification of standard induction with Isatuximab or by establishing a post-induction therapy for eradication of MRD and thereby evaluates in parallel two different strategies.
Trial Details
NCT Number NCT06648889
Lead Sponsor Goethe University
Collaborators: Sanofi
Conditions T-ALL
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov