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A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. 4 versions Re-verified since Jun 27, 2023, no change to tracked fieldsv19-v22
  2. Results first posted: Mar 14, 2023
    • Primary endpoints revised (3)
    • Secondary endpoints revised (3)
    • Study arms: 3 to 7
    v18
  3. Primary completion date: Sep 2020 to Aug 10, 2021
    • Study completion date: Sep 2035 to Jul 2036
    v17
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 80 to confirmed 167
    • Site details revised at 3 of 3 sites
    v16
  5. Eligibility criteria expanded, about 17 wordsv15
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Sep 2019 to Sep 2020
    • Study completion date: Sep 2034 to Sep 2035
    v14
  2. Re-verified, no change to tracked fieldsv13
  3. Primary completion date: Jan 2020 to Sep 2019
    • Study completion date: Jan 2032 to Sep 2034
    • Start date: Jan 2014 to Feb 11, 2014
    • Site contacts updated at 3 of 3 sites
    v12
  4. Site contacts updated at 1 of 3 sitesv11
  5. Study sites: 2 to 3v10
  6. Re-verified, no change to tracked fieldsv9
  7. Primary completion date: Jan 2017 to Jan 2020
    • Study sites: 1 to 2
    v8
  8. Eligibility criteria expanded, about 208 wordsv7
  9. Secondary endpoints revised (3)v6
  10. Re-verified, no change to tracked fieldsv5
  11. Study completion date: Jan 2032v4
  12. Enrollment target: 80v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2014
    • Site details revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 or refractory leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia. This is a phase 1/2 study designed to determine the maximum tolerated dose of the CAR+ T cells as well as to determine the efficacy. The phase 1 cohort is restricted to those patients who have already had an allogeneic hematopoietic cell transplant (HCT). The phase 2 is open to all patients regardless of having a history of HCT.
Trial Details
NCT Number NCT02028455
Lead Sponsor Seattle Children's Hospital
Conditions
(from sponsor)		 CD19+ Acute Leukemia
Related terms Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 167 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov