deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01611090

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Sponsor: Janssen Research & Development, LLC

Updated 21 times since 2017 Last updated: Feb 20, 2020 Started: Sep 19, 2012 Primary completion: Jan 23, 2019 Completion: Jan 23, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma and is currently completed. Janssen Research & Development, LLC leads this study, which shows 21 recorded versions since 2012 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Sep 2017 · 3 months · monthly snapshot~Sep 2017 – ~Nov 2017 · 2 months · monthly snapshot~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Oct 2018 · 2 months · monthly snapshot~Oct 2018 – ~Dec 2018 · 2 months · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2020 · 13 months · monthly snapshot~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 9 months · monthly snapshot

Change History

21 versions recorded
  1. Oct 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Oct 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE3

Show 16 earlier versions
  1. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

  2. Apr 2020 — Jan 2021 [monthly]

    Completed PHASE3

  3. Mar 2019 — Apr 2020 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Feb 2019 — Mar 2019 [monthly]

    Active Not Recruiting PHASE3

  5. Jan 2019 — Feb 2019 [monthly]

    Active Not Recruiting PHASE3

  6. Dec 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE3

  7. Oct 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE3

  8. Aug 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE3

  9. Jul 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE3

  10. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE3

  11. Dec 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  12. Nov 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE3

  13. Sep 2017 — Nov 2017 [monthly]

    Active Not Recruiting PHASE3

  14. Jun 2017 — Sep 2017 [monthly]

    Active Not Recruiting PHASE3

  15. Feb 2017 — Jun 2017 [monthly]

    Active Not Recruiting PHASE3

  16. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Sep 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen Research & Development, LLC
  • Pharmacyclics LLC.
Data source: Janssen Research & Development, LLC

For direct contact, visit the study record on ClinicalTrials.gov .