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PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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

Record History

The 50 most recent of 70 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv70
  2. Study completion date: Sep 30, 2025 to Sep 30, 2034v69
  3. Start date: Nov 28, 2011 to Jan 5, 2012v68
  4. Re-verified, no change to tracked fieldsv67
  5. Study completion date: May 1, 2025 to Sep 30, 2025v66
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv65
  2. Study completion date: May 1, 2024 to May 1, 2025v64
  3. Results first posted: Jul 11, 2018v63 Show 4 more changesShow less
    • Primary endpoint revised
    • Study completion date: May 1, 2018 to May 1, 2024
    • Secondary endpoints shortened, about 32 words
    • Publications: details revised at 1 of 17 entries
  4. Re-verified, no change to tracked fieldsv62
  5. Primary completion date changed from estimate of May 1, 2018 to Jun 20, 2014v61
  6. 3 versions Re-verified since Nov 14, 2017, no change to tracked fieldsv58-v60
  7. Start date: Nov 22, 2011 to Nov 28, 2011v57
  8. Re-verified, no change to tracked fieldsv56
  9. Eligibility criteria revisedv55
  10. 7 versions Re-verified since Apr 18, 2017, no change to tracked fieldsv48-v54
  11. Primary completion date: May 1, 2017 to May 1, 2018
    • Study completion date: Sep 30, 2017 to May 1, 2018
    v47
  12. 2 versions Re-verified since Jan 20, 2017, no change to tracked fieldsv45-v46
  13. Primary completion date: May 2017 to May 1, 2017
    • Study completion date: Sep 2017 to Sep 30, 2017
    • Start date: Nov 2011 to Nov 22, 2011
    v44
  14. 9 versions Re-verified since May 27, 2015, no change to tracked fieldsv35-v43
  15. Primary completion date: Sep 2015 to May 2017
    • Study completion date: Sep 2015 to Sep 2017
    v34
  16. Eligibility criteria expanded, about 6 wordsv33
  17. Study description revisedv32
  18. Study description shortened, about 26 wordsv31
  19. Re-verified, no change to tracked fieldsv30
  20. Enrollment target: 70 to 86v29
  21. Primary completion date: Sep 2014 to Sep 2015v28
  22. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 86 to confirmed 70
    • Site details revised
    v27
  23. 3 versions Re-verified since Dec 6, 2013, no change to tracked fieldsv24-v26
  24. Eligibility criteria expanded, about 1 word
    • Study description expanded, about 1 word
    v23
  25. 2 versions Re-verified since Aug 9, 2013, no change to tracked fieldsv21-v22
  • 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.
Background: \- Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) are types of blood or lymph node cancers that mostly affect the elderly. CLL/SLL both create abnormal white blood cells that hurt the immune system and make it more difficult to fight infections. These cancers are usually diagnosed after age 50; more than half of the people with CLL/SLL are over age 70. Elderly people often do not respond well to standard chemotherapy for CLL/SLL. They may have other health problems that make chemotherapy difficult. In addition, individuals who have a genetic abnormality called 17p deletion also do not respond well to standard treatments for CLL/SLL. Researchers want to test a new cancer treatment drug, PCI-32765, to see if it can treat CLL/SLL in these hard-to-treat groups. Objectives: \- To see if PCI-32765 is a safe and effective treatment for CLL/SLL in older people and people with 17p deletion. Eligibility: * Individuals over 65 years of age who have CLL/SLL. * Individuals at least 18 years of age who have CLL/SLL and 17p deletion. Design: * Participants will be screened with a medical history, physical exam, and imaging studies. Blood and urine samples will be taken. Optional bone marrow and lymph node biopsies may also be taken. * Participants will take PCI-32765 capsules every day for 28 days (one cycle of treatment). Treatment will be monitored with frequent blood tests and clinic visits. * PCI-32765 will be given for six cycles of treatment. Those who benefit from the drug will continue to take it as long as there are no side effects and the disease does not progress. Those who do not benefit will stop treatment and have regular followup exams.
Trial Details
NCT Number NCT01500733
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Leukemia, Leukemia, Lymphocytyc, CLL (Chronic Lymphocytic Leukemia), SLL (Small Lymphocytic Lymphoma)
Related terms Leukemia, Leukemia, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Lymphoid
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov