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Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Dec 18, 2025, no change to tracked fieldsv45-v46
  2. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2027v44
  3. Re-verified, no change to tracked fieldsv43
  4. Primary and study completion dates: Jun 30, 2024 to Jun 30, 2025 Site contact updatedv42 Show 1 more changeShow less
    • Site contact updated
  5. 2 versions Re-verified since Nov 8, 2023, no change to tracked fieldsv40-v41
Show 38 earlier versionsHide 38 earlier versions
  1. Primary and study completion dates: Jun 30, 2023 to Jun 30, 2024v39
  2. 3 versions Re-verified since Mar 20, 2020, no change to tracked fieldsv36-v38
  3. Primary endpoints revised (5) Eligibility criteria expanded, about 5 wordsv35 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary endpoints revised (5)v34 See this version in full on ClinicalTrials.gov ↗
  5. Primary endpoints: 1 to 5 Primary and study completion dates: Jun 2023 to Jun 30, 2023 · Interventions: Cladribine (Drug), Rituximab (Drug) to Cladribine (Drug), Laboratory Biomarker Analysis (Other), Rituximab (Biological) · Study description shortened, about 132 words · 4 morev33 Show 7 more changesShow less
    • Primary and study completion dates: Jun 2023 to Jun 30, 2023
    • Interventions: Cladribine (Drug), Rituximab (Drug) to Cladribine (Drug), Laboratory Biomarker Analysis (Other), Rituximab (Biological)
    • Study description shortened, about 132 words
    • Study site revised
    • Collaborator revised
    • Eligibility criteria shortened, about 5 words
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Primary completion date: Jun 2019 to Jun 2023 Completion date: Jun 2020 to Jun 2023v32 Show 1 more changeShow less
    • Completion date: Jun 2020 to Jun 2023
  7. Completion date: Jun 2019 to Jun 2020v31
  8. Re-verified, no change to tracked fieldsv30
  9. Study description shortened, about 43 wordsv29 See this version in full on ClinicalTrials.gov ↗
  10. Primary and study completion dates: Jun 1, 2019 to Jun 2019v28
  11. Primary completion date: Sep 2018 to Jun 1, 2019 Completion date: Jun 1, 2019 · Start date: Sep 2004 to Jun 10, 2004v27 Show 2 more changesShow less
    • Completion date: Jun 1, 2019
    • Start date: Sep 2004 to Jun 10, 2004
  12. Re-verified, no change to tracked fieldsv26
  13. Primary completion date: Sep 2017 to Sep 2018v25
  14. Primary completion date: Sep 2016 to Sep 2017v24
  15. Re-verified, no change to tracked fieldsv23
  16. Study site revisedv22 See this version in full on ClinicalTrials.gov ↗
  17. Re-verified, no change to tracked fieldsv21
  18. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 74 to 150 · Eligibility criteria revised · Study description revised · 1 morev20 Show 4 more changesShow less
    • Enrollment target: 74 to 150
    • Eligibility criteria revised
    • Study description revised
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  19. Trial status: Recruiting to Active, Not Recruiting Site details revisedv19 Show 1 more changeShow less
    • Site details revised
  20. Re-verified, no change to tracked fieldsv18
  21. Eligibility criteria revisedv17 See this version in full on ClinicalTrials.gov ↗
  22. Re-verified, no change to tracked fieldsv16
  23. Start date: Sep 2008 to Sep 2004v15
  24. Re-verified, no change to tracked fieldsv14
  25. Study description shortened, about 8 wordsv13 See this version in full on ClinicalTrials.gov ↗
  26. Trial status: Active, Not Recruiting to Recruiting Study description shortened, about 111 words · Site details revisedv12 Show 2 more changesShow less
    • Study description shortened, about 111 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  27. Trial status: Recruiting to Active, Not Recruiting Site details revisedv11 Show 1 more changeShow less
    • Site details revised
  28. 4 versions Re-verified since Sep 30, 2010, no change to tracked fieldsv7-v10
  29. Enrollment target: 44 to 74 Primary completion date: Sep 2011 to Sep 2016 · Study site revisedv6 Show 2 more changesShow less
    • Primary completion date: Sep 2011 to Sep 2016
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  30. Trial status: Active, Not Recruiting to Recruiting Primary completion date: Sep 2012 to Sep 2011 · Eligibility criteria shortened, about 7 words · Study description revised · 1 morev5 Show 4 more changesShow less
    • Primary completion date: Sep 2012 to Sep 2011
    • Eligibility criteria shortened, about 7 words
    • Study description revised
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  31. Trial status: Recruiting to Active, Not Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  32. Start date: Jun 2004 to Sep 2008 Primary completion date: Sep 2012 · Interventions: Cladribine (2-CDA) (Drug), Rituximab (Drug) to Cladribine (Drug), Rituximab (Drug) · Study arms: 0 to 1v3 Show 3 more changesShow less
    • Primary completion date: Sep 2012
    • Interventions: Cladribine (2-CDA) (Drug), Rituximab (Drug) to Cladribine (Drug), Rituximab (Drug)
    • Study arms: 0 to 1
  33. Eligibility criteria expanded, about 34 words Collaborators expanded, about 2 wordsv2 Show 1 more changeShow less
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  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.
This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.
Trial Details
NCT Number NCT00412594
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov