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Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Re-verified, no change to tracked fieldsv23
  2. Minor Study completion date: Jun 30, 2025 to Mar 2036v22
  3. Minor Re-verified, no change to tracked fieldsv21
  4. Notable Primary completion date: Jan 27, 2023 to May 13, 2021
    • Eligibility criteria revised
    v20
  5. Notable Results first posted: Jul 20, 2023
    • Primary endpoint revised
    • Secondary endpoints revised (16)
    v19
Show 17 earlier versionsHide 17 earlier versions
  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 18 to confirmed 11
    • Primary completion date changed from estimate of Dec 31, 2024 to Jan 27, 2023
    • Site details revised at 4 of 4 sites
    v18
  2. Minor Site details revised at 1 of 4 sitesv17
  3. Minor Study description expanded, about 463 wordsv16
  4. Minor Eligibility criteria revised
    • Secondary endpoints: details revised at 5 of 16 entries
    v15
  5. Notable Primary completion date: Sep 30, 2022 to Dec 31, 2024v14 Show 5 more changesShow less
    • Primary endpoints: 2 to 1
    • Study completion date: Sep 30, 2024 to Jun 30, 2025
    • Eligibility criteria expanded, about 238 words
    • Secondary endpoints revised (16)
    • Study description shortened, about 391 words
  6. Minor Primary completion date: Sep 2022 to Sep 30, 2022
    • Study completion date: Sep 2024 to Sep 30, 2024
    • Start date: May 2016 to Jun 23, 2016
    • Secondary endpoints revised (16)
    v13
  7. Notable Primary completion date: Sep 2021 to Sep 2022
    • Study completion date: Jun 2036 to Sep 2024
    v12
  8. Minor Site contacts updated at 1 of 4 sitesv11
  9. Minor Site contacts updated at 1 of 4 sitesv10
  10. Notable Primary completion date: Sep 2019 to Sep 2021
    • Study completion date: Jun 2034 to Jun 2036
    • Study sites revised (4)
    v9
  11. Minor Site contacts updated at 1 of 4 sitesv8
  12. Minor Study sites revised (4)v7
  13. Minor Collaborators: 1 to 2v6
  14. Minor Site details revised at 1 of 4 sitesv5
  15. Notable Trial status: Suspended to Recruiting
    • Study completion date: Jun 2034
    • Site details revised at 4 of 4 sites
    v4
  16. Stopped Trial status: Recruiting to Suspended Sponsor's reason: Temporarily suspended due to manufacturing issues
    • Site details revised at 4 of 4 sites
    v3
  17. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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.
703 trials monitored
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and 2 more diseases
This phase I/II trial studies the side effects and best dose of gene therapy in treating patients with human immunodeficiency virus (HIV)-related lymphoma that did not respond to therapy or came back after an original response receiving stem cell transplant. In gene therapy, small stretches of deoxyribonucleic acid (DNA) called "anti-HIV genes" are introduced into the stem cells in the laboratory to make the gene therapy product used in this study. The type of anti-HIV genes and therapy in this study may make the patient's immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with HIV-1.
Trial Details
NCT Number NCT02797470
Lead Sponsor AIDS Malignancy Consortium
Collaborators: National Cancer Institute (NCI), California Institute for Regenerative Medicine (CIRM)
Conditions
(from sponsor)
HIV Infection, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Plasmablastic Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Non-Hodgkin Lymphoma, Recurrent Burkitt Lymphoma, Recurrent Follicular Lymphoma, Stage III Follicular Lymphoma +3 more
Related terms Burkitt Lymphoma, HIV Infections, Hodgkin Disease, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Plasmablastic Lymphoma
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov