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A Pediatric Trial of Genetically Modified Autologous T Cells Directed Against CD19 for Relapsed CD19+ Acute Lymphoblastic Leukemia

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. 9 versions Re-verified since Jul 26, 2019, no change to tracked fieldsv13-v21
  2. Enrollment target: estimated 18 to confirmed 6
    • Primary completion date changed from estimate of Jan 2031 to Jan 7, 2015
    • Study completion date: Jan 2031 to Jan 7, 2030
    • Start date: Dec 2012 to Mar 25, 2012
    v12
  3. 2 versions Re-verified since May 1, 2017, no change to tracked fieldsv10-v11
  4. Primary completion date: Jan 2016 to Jan 2031v9
  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  2. Primary completion date: Jan 2015 to Jan 2016
    • Study completion date: Jan 2031
    v6
  3. Primary completion date: Jan 2015
    • Eligibility criteria shortened, about 27 words
    v5
  4. Eligibility criteria shortened, about 17 wordsv4
  5. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v3
  6. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date: Dec 2012
    • Eligibility criteria expanded, about 25 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients with relapsed leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use a patient's own T cells, which can be genetically modified to expresses a chimeric antigen receptor(CAR). The CAR enables the T cell to recognize and kill the leukemic cells though the recognition of CD19, a protein expressed on the surface of the majority of pediatric ALL. This is a phase I study designed to determine the maximum tolerated dose of the CAR+ T cells and define the toxicity of the treatment. As a secondary aim, we will be looking at the efficacy of the T cells on eradicating the patient's leukemic cells.
Trial Details
NCT Number NCT01683279
Lead Sponsor Seattle Children's Hospital
Conditions
(from sponsor)		 B Cell Leukemia
Related terms Leukemia, B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov