In Vitro Expanded Allogeneic Epstein-Barr Virus Specific Cytotoxic T-Lymphocytes (EBV-CTLs) Genetically Targeted to the CD19 Antigen in B-cell Malignancies

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
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Record History

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  1. Primary and study completion pushed from Sep 2026 to Sep 2027 Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Interventions: Biological/Genetically Modified T cells (Biological), Cyclophosphamide-based chemotherapy (Drug) to Biological/Genetically Modified T cells (Biological), Cyclophosphamide-based chemotherapy (Drug)
    • Eligibility criteria expanded, about 41 words
    • Publications: details revised at 1 of 1 entry
  2. 4 versions Re-verified since Nov 27, 2023, no change to tracked fieldsv32-v35
  3. Primary and study completion dates: Sep 2023 to Sep 2026v31
  4. Re-verified, no change to tracked fieldsv30
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 24 to confirmed 19
    • Site details revised
    v29
Show 27 earlier versionsHide 27 earlier versions
  1. Re-verified, no change to tracked fieldsv28
  2. Primary and study completion dates: Sep 2022 to Sep 2023v27
  3. Primary and study completion dates: Sep 2021 to Sep 2022v26
  4. Re-verified, no change to tracked fieldsv25
  5. Primary and study completion dates: Sep 2020 to Sep 2021
    • Study site revised
    v24
  6. Enrollment target: 12 to 24v23 Show 4 more changesShow less
    • Primary endpoint revised
    • Secondary endpoints revised (3)
    • Study description shortened, about 64 words
    • Eligibility criteria expanded, about 1 word
  7. Study description expanded, about 64 wordsv22
  8. Primary and study completion dates: Sep 2019 to Sep 2020v21
  9. Primary and study completion dates: Sep 2018 to Sep 2019
    • Interventions: Biological/Genetically Modified T cells (Biological) to Biological/Genetically Modified T cells (Biological), Cyclophosphamide-based chemotherapy (Drug)
    • Eligibility criteria expanded, about 237 words
    v20
  10. Re-verified, no change to tracked fieldsv19
  11. Primary and study completion dates: Sep 2017 to Sep 2018v18
  12. Re-verified, no change to tracked fieldsv17
  13. Primary and study completion dates: Sep 2016 to Sep 2017v16
  14. Collaborators shortened, about 7 wordsv15
  15. Enrollment target: 26 to 12
    • Eligibility criteria expanded, about 38 words
    • Study title shortened, about 12 words
    v14
  16. Primary and study completion dates: Sep 2015 to Sep 2016v13
  17. Re-verified, no change to tracked fieldsv12
  18. Eligibility criteria expanded, about 53 words
    • Study site revised
    • Collaborators expanded, about 7 words
    v11
  19. Primary and study completion dates: Sep 2014 to Sep 2015v10
  20. 3 versions Re-verified since Oct 29, 2012, no change to tracked fieldsv7-v9
  21. Enrollment target: 52 to 26v6 Show 4 more changesShow less
    • Primary endpoint revised
    • Interventions: allogeneic Epstein - Barr virus specific cytotoxic T lymphocytes (EBV-CTLs) (Biological) to Biological/Genetically Modified T cells (Biological)
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (3)
  22. Re-verified, no change to tracked fieldsv5
  23. Eligibility criteria shortened, about 17 wordsv4
  24. Interventions: EBV specific T-cells (Biological) to allogeneic Epstein - Barr virus specific cytotoxic T lymphocytes (EBV-CTLs) (Biological)v3
  25. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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 purpose of this study is to test the safety of giving the patient special cells from a donor called "Modified T-cells". The goal is to assess the toxicities of T-cells for patients with relapsed B cell leukemia or lymphoma after a blood SCT organ SCT or for patients who are at high risk for relapse of their B cell leukemia or lymphoma.
Trial Details
NCT Number NCT01430390
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions
(from sponsor)		 Acute Lymphocytic Leukemia, Lymphoma
Related terms Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov