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Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

Study acronym: ElevateTN
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Sep 30, 2025 to Sep 15, 2026v36
  2. 8 versions Re-verified since Nov 8, 2023, no change to tracked fieldsv28-v35
  3. Study sites: 154 to 155v27
  4. Re-verified, no change to tracked fieldsv26
  5. Results first posted: Jan 10, 2023 Primary endpoint revised · Study sites: 145 to 154 · Primary completion date: Feb 2019 to Feb 8, 2019 · 6 morev25 Show 9 more changesShow less
    • Primary endpoint revised
    • Study sites: 145 to 154
    • Primary completion date: Feb 2019 to Feb 8, 2019
    • Completion date: Jul 2021 to Sep 30, 2025
    • Start date: Sep 2015 to Jun 26, 2015
    • Eligibility criteria expanded, about 956 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 165 words
    • Study title shortened, about 12 words

    See this version in full on ClinicalTrials.gov ↗

Show 23 earlier versionsHide 23 earlier versions
  1. Start date: Jun 2015 to Sep 2015v24
  2. Completion date: May 2020 to Jul 2021v23
  3. Study sites: 147 to 145 Primary completion date changed from estimate of Dec 2019 to Feb 2019 · Completion date: May 2020v22 Show 2 more changesShow less
    • Primary completion date changed from estimate of Dec 2019 to Feb 2019
    • Completion date: May 2020
  4. Study sites: 15 to 147v21
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 510 to confirmed 535 · Site details revised at 15 of 15 sitesv20 Show 2 more changesShow less
    • Enrollment target: estimated 510 to confirmed 535
    • Site details revised at 15 of 15 sites
  6. Interventions: ACP-196 (Drug), Chlorambucil (Drug), Obinutuzumab (Drug) to Acalabrutinib (Drug), Chlorambucil (Drug), Obinutuzumab (Drug)v19
  7. 2 versions Re-verified since Aug 8, 2016, no change to tracked fieldsv17-v18
  8. Study sites: 14 to 15 Eligibility criteria shortened, about 8 wordsv16 Show 1 more changeShow less
    • Eligibility criteria shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  9. Re-verified, no change to tracked fieldsv15
  10. Primary completion date: Aug 2019 to Dec 2019 Study title expanded, about 1 wordv14 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. 2 versions Re-verified since Mar 15, 2016, no change to tracked fieldsv12-v13
  12. Study sites: 13 to 14v11
  13. Study title expanded, about 3 wordsv10 See this version in full on ClinicalTrials.gov ↗
  14. 4 versions Re-verified since Nov 4, 2015, no change to tracked fieldsv6-v9
  15. Study sites: 1 to 13v5
  16. Trial status: Not Yet Recruiting to Recruiting Start date: Jul 2015 to Jun 2015 · Site details revisedv4 Show 2 more changesShow less
    • Start date: Jul 2015 to Jun 2015
    • Site details revised
  17. 2 versions Re-verified since Jun 19, 2015, no change to tracked fieldsv2-v3
  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 Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria. 2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)
Trial Details
NCT Number NCT02475681
Lead Sponsor Acerta Pharma BV
Conditions Chronic Lymphocytic Leukemia
Enrollment 535 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov