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Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 12 words
  2. Study sites: 32 to 29 Completion date: Dec 29, 2028 to Dec 11, 2028v21 Show 1 more changeShow less
    • Completion date: Dec 29, 2028 to Dec 11, 2028
  3. Results first posted: Oct 15, 2025 Primary endpoints: 1 to 3v20 Show 1 more changeShow less
    • Primary endpoints: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv19
  5. Phase: Phase 1 to Phase 1/2v18
Show 16 earlier versionsHide 16 earlier versions
  1. Re-verified, no change to tracked fieldsv17
  2. Enrollment target: 89 to 113 Completion date: Aug 25, 2023 to Dec 29, 2028v16 Show 1 more changeShow less
    • Completion date: Aug 25, 2023 to Dec 29, 2028
  3. Re-verified, no change to tracked fieldsv15
  4. Enrollment target: estimated 114 to confirmed 89 Study sites: 33 to 32v14 Show 1 more changeShow less
    • Study sites: 33 to 32
  5. Re-verified, no change to tracked fieldsv13
  6. Start date: Nov 19, 2014 to Dec 29, 2014v12
  7. Phase: Phase 1/2 to Phase 1 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: 80 to 114 · Study sites: 11 to 33 · 4 morev11 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 80 to 114
    • Study sites: 11 to 33
    • Primary and study completion dates: May 2023 to Aug 25, 2023
    • Start date: Feb 2015 to Nov 19, 2014
    • Eligibility criteria expanded, about 7 words
    • Collaborators expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  8. Enrollment target: 126 to 80 Primary and study completion dates: Oct 2022 to May 2023 · Eligibility criteria shortened, about 38 words · Site details revised at 2 of 11 sites · 1 morev10 Show 4 more changesShow less
    • Primary and study completion dates: Oct 2022 to May 2023
    • Eligibility criteria shortened, about 38 words
    • Site details revised at 2 of 11 sites
    • Study arms: 6 to 5

    See this version in full on ClinicalTrials.gov ↗

  9. Enrollment target: 80 to 126 Primary completion date: Apr 2022 to Oct 2022 · Completion date: Jul 2022 to Oct 2022 · Interventions: acalabrutinib (Drug), rituximab (IV) (Drug) to Lenalidomide (Drug), acalabrutinib (Drug), rituximab (IV) (Drug) · 5 morev9 Show 8 more changesShow less
    • Primary completion date: Apr 2022 to Oct 2022
    • Completion date: Jul 2022 to Oct 2022
    • Interventions: acalabrutinib (Drug), rituximab (IV) (Drug) to Lenalidomide (Drug), acalabrutinib (Drug), rituximab (IV) (Drug)
    • Eligibility criteria expanded, about 81 words
    • Study description shortened, about 7 words
    • Study title revised
    • Study arms: 2 to 6
    • Collaborators shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  10. Re-verified, no change to tracked fieldsv8
  11. Phase: Phase 1 to Phase 1/2 Trial status: Active, Not Recruiting to Recruiting · Enrollment target: 40 to 80 · Study sites: 10 to 11 · 2 morev7 Show 5 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 40 to 80
    • Study sites: 10 to 11
    • Study description expanded, about 25 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  12. Primary completion date: Aug 2018 to Apr 2022 Start date: Jul 2014 to Feb 2015 · Study sites: 3 to 10 · Completion date: Jul 2022 · 2 morev6 Show 5 more changesShow less
    • Start date: Jul 2014 to Feb 2015
    • Study sites: 3 to 10
    • Completion date: Jul 2022
    • Eligibility criteria expanded, about 45 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  13. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 36 to confirmed 40 · Study sites: 4 to 3 · Interventions: ACP-196 (Drug), rituximab (IV) (Drug) to acalabrutinib (Drug), rituximab (IV) (Drug) · 3 morev5 Show 6 more changesShow less
    • Enrollment target: estimated 36 to confirmed 40
    • Study sites: 4 to 3
    • Interventions: ACP-196 (Drug), rituximab (IV) (Drug) to acalabrutinib (Drug), rituximab (IV) (Drug)
    • Eligibility criteria expanded, about 12 words
    • Collaborators expanded, about 3 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  14. Re-verified, no change to tracked fieldsv4
  15. Primary completion date: Sep 2015 to Aug 2018 Enrollment target: 32 to 36 · Study sites: 7 to 4 · Interventions: ACP-196 (Drug) to ACP-196 (Drug), rituximab (IV) (Drug) · 2 morev3 Show 5 more changesShow less
    • Enrollment target: 32 to 36
    • Study sites: 7 to 4
    • Interventions: ACP-196 (Drug) to ACP-196 (Drug), rituximab (IV) (Drug)
    • Study title expanded, about 6 words
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  16. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 7v2 Show 1 more changeShow less
    • Study sites: 1 to 7
  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.
Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL. Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR. Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL
Trial Details
NCT Number NCT02180711
Lead Sponsor Acerta Pharma BV
Collaborators: AstraZeneca
Conditions Non Hodgkin Lymphoma
Enrollment 113 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov