Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

StatusRecruiting
PhasePhase 2
Started

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Record History

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  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 updated
    v42
  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 words
    v35
  4. Primary endpoints revised (5)v34
  5. Primary endpoints: 1 to 5v33 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
  6. Primary and study completion dates pushed to Jun 2023v32
  7. Study completion date: Jun 2019 to Jun 2020v31
  8. Re-verified, no change to tracked fieldsv30
  9. Study description shortened, about 43 wordsv29
  10. Primary and study completion dates: Jun 1, 2019 to Jun 2019v28
  11. Primary completion date: Sep 2018 to Jun 1, 2019
    • Study completion date: Jun 1, 2019
    • Start date: Sep 2004 to Jun 10, 2004
    v27
  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
  17. Re-verified, no change to tracked fieldsv21
  18. Trial status: Active, Not Recruiting to Recruitingv20 Show 4 more changesShow less
    • Enrollment target: 74 to 150
    • Eligibility criteria revised
    • Study description revised
    • Site details revised
  19. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v19
  20. Re-verified, no change to tracked fieldsv18
  21. Eligibility criteria revisedv17
  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
  26. Trial status: Active, Not Recruiting to Recruiting
    • Study description shortened, about 111 words
    • Site details revised
    v12
  27. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v11
  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 revised
    v6
  30. Trial status: Active, Not Recruiting to Recruitingv5 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
  31. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  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 1
    v3
  33. Eligibility criteria expanded, about 34 words
    • Collaborators expanded, about 2 words
    v2
  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.
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
(from sponsor)		 Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia
Related terms Leukemia, Hairy Cell
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov