Treatment of Relapsed or Chemotherapy Refractory Chronic Lymphocytic Leukemia or Indolent B Cell Lymphoma Using Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  1. 3 versions Re-verified since Jun 24, 2024, no change to tracked fieldsv40-v42
  2. Primary and study completion dates: Dec 2023 to Dec 2026v39
  3. Primary and study completion dates: Dec 2022 to Dec 2023v38
  4. Primary and study completion dates: Dec 2021 to Dec 2022v37
  5. Re-verified, no change to tracked fieldsv36
Show 34 earlier versionsHide 34 earlier versions
  1. Primary and study completion dates: Dec 2020 to Dec 2021v35
  2. Primary and study completion dates: Dec 2019 to Dec 2020v34
  3. Primary and study completion dates: Dec 2018 to Dec 2019v33
  4. Primary and study completion dates: Dec 2017 to Dec 2018
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 50
    • Site details revised
    v32
  5. Start date: Mar 2007 to Mar 21, 2007v31
  6. Primary and study completion dates: Dec 2016 to Dec 2017v30
  7. 2 versions Re-verified since Aug 18, 2015, no change to tracked fieldsv28-v29
  8. Primary and study completion dates: Dec 2015 to Dec 2016
    • Study site revised
    v27
  9. Primary and study completion dates: Dec 2014 to Dec 2015
    • Study description expanded, about 71 words
    v26
  10. Trial status: Suspended to Recruitingv25 Show 4 more changesShow less
    • Enrollment target: 36 to 30
    • Eligibility criteria expanded, about 26 words
    • Study description expanded, about 10 words
    • Site details revised
  11. Trial status: Recruiting to Suspended
    • Site details revised
    v24
  12. Re-verified, no change to tracked fieldsv23
  13. Primary and study completion dates: Dec 2013 to Dec 2014v22
  14. 2 versions Re-verified since Sep 19, 2012, no change to tracked fieldsv20-v21
  15. Phase: Phase 1 to Phase 1/2v19 Show 9 more changesShow less
    • Primary completion date: Dec 2009 to Dec 2013
    • Primary endpoints: 1 to 2
    • Study completion date: Dec 2013
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 9 words
    • Publications: details revised at 1 of 3 entries
    • Study title expanded, about 12 words
    • Study arms: 0 to 1
    • Eligibility criteria shortened, about 3 words
  16. Re-verified, no change to tracked fieldsv18
  17. Trial status: Suspended to Recruiting
    • Site details revised
    v17
  18. Study description expanded, about 23 wordsv16
  19. Interventions: cyclophosphamide (Drug), therapeutic autologous lymphocytes (Drug) to cyclophosphamide (Drug), therapeutic autologous lymphocytes (Biological)v15
  20. Trial status: Recruiting to Suspended
    • Site details revised
    v14
  21. 2 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv12-v13
  22. Study Status, Contacts/Locationsv11
  23. Interventions: chemotherapy (Procedure), cyclophosphamide (Drug), genetically engineered lymphocyte therapy (Procedure), therapeutic autologous… to cyclophosphamide (Drug), therapeutic autologous lymphocytes (Drug)v10
  24. Eligibility criteria shortened, about 7 wordsv9
  25. Re-verified, no change to tracked fieldsv8
  26. Primary completion date: Dec 2009v7
  27. Interventions: biological therapy (Procedure), chemotherapy (Procedure), cyclophosphamide (Drug), genetically engineered lymphocyte therapy (Procedure)… to chemotherapy (Procedure), cyclophosphamide (Drug), genetically engineered lymphocyte therapy (Procedure), therapeutic autologous…v6
  28. Re-verified, no change to tracked fieldsv5
  29. Study Status, Contacts/Locationsv4
  30. Study description expanded, about 8 words
    • Eligibility criteria expanded, about 1 word
    v3
  31. Interventions: biological therapy (Procedure), chemotherapy (Procedure), cyclophosphamide (Drug), genetically engineered lymphocyte therapy (Procedure)… to biological therapy (Procedure), chemotherapy (Procedure), cyclophosphamide (Drug), genetically engineered lymphocyte therapy (Procedure)…v2 Show 4 more changesShow less
    • Secondary endpoints revised (2)
    • Study description shortened, about 7 words
    • Eligibility criteria shortened, about 1 word
    • Study title expanded, about 2 words
  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.
RATIONALE: Using T cells from the patient that have been treated in the laboratory may help the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving laboratory-treated T cells together with cyclophosphamide may kill more cancer cells. PURPOSE: This is a two-stage protocol, consisting of a single-institution phase I safety study and multi-institution phase IIa extension study.
Trial Details
NCT Number NCT00466531
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Leukemia
Related terms Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov