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Daratumumab in VHR T-ALL Treated According to the ALL National Treatment Program

Study acronym: DARATALL-VHR
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v4
  2. Study sites: 1 to 3v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jan 2029 to Oct 2029
    • Start date changed from estimate of May 2024 to Oct 17, 2024
    • Study sites: 0 to 1
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to test daratumumab in adult very high risk T-lineage lymphoblastic leukemia. The main question it aims to answer is wether the addition of daratumumab daratumumab to the national standard of care is able to increase the rate of MRD-negative patients after induction therapy. Participants will be treated with: • daratumumab in combination with a pediatric-inspired treatment scheme - as in the previous GIMEMA LAL1913 protocol.
Trial Details
NCT Number NCT06253637
Lead Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions
(from sponsor)		 T-Lymphocytic Leukemia, Acute
Related terms Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov