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NCT04008706 · ClinicalTrials.gov registry record · Phase 3

Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients

A Phase 3 study of Chronic Lymphocytic Leukemia, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
552
Enrollment target
20
Study locations

NCT04008706 is a Phase 3 study of Chronic Lymphocytic Leukemia that has completed, run by AstraZeneca. The registered enrollment target is 552 participants, above the 179-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (208% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT04008706, a Phase 3 study of Chronic Lymphocytic Leukemia, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
552 participants
Enrollment target
20
Study locations

Study Summary

This is a global, Phase IIIb, multicenter, open-label, single-arm study to evaluate the safety and efficacy of acalabrutinib 100 mg twice daily (bid) in approximately 540 participants with chronic lymphocytic leukemia (CLL). Participants will be enrolled into 3 following cohorts: treatment-naive (TN), relapsed/refractory (R/R), and prior ibrutinib therapy. For this study, participants in the UK will be enrolled ONLY into the R/R cohort or the prior ibrutinib cohort. Participants in the US will be enrolled ONLY into the TN or R/R cohort. Participants will remain on study intervention until completion of 48 cycles (28 days per cycle), or until study intervention discontinuation due to, for example disease progression, or toxicity, withdrawal of consent, loss to follow-up, death, or study termination by the sponsor whichever occurs first. The duration of the study will be approximately 72 months from the first participant enrolled. This duration includes an estimated 24-month recruitment time and an assumed 48 cycles of study intervention (28 days per cycle); additional study time will be accrued during the Disease Follow up period for those participants remaining on study intervention after completion of 48 cycles prior to the final data cutoff (DCO) (the amount of time will vary by participant).

Conditions Studied

Chronic Lymphocytic Leukemia

Interventions

  • DRUG Acalabrutinib

Study Locations (20)

California

  • Research Site - Long Beach
  • Research Site - Redlands
  • Research Site - Whittier

Florida

  • Research Site - Fort Myers
  • Research Site - Jacksonville
  • Research Site - St. Petersburg

Illinois

  • Research Site - Normal
  • Research Site - Peoria

Indiana

  • Research Site - Fort Wayne
  • Research Site - Indianapolis

Tennessee

  • Research Site - Chattanooga
  • Research Site - Nashville

Arizona

  • Research Site - Chandler

Georgia

  • Research Site - Marietta

Louisiana

  • Research Site - Shreveport

Trial Details

FieldValue
Enrollment Target 552 participants
Start Date 2019-09-17
Est. Completion 2025-11-04
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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What the Registry Record Tells You About NCT04008706

The ClinicalTrials.gov registry entry for NCT04008706 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 552 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 179-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (208% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Acalabrutinib is the first listed.

NCT04008706 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT04008706 about?

NCT04008706 is a clinical study titled "Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients". This is a global, Phase IIIb, multicenter, open-label, single-arm study to evaluate the safety and efficacy of acalabrutinib 100 mg twice daily (bid) in approximately 540 participants with chronic lymphocytic leukemia (CLL). Participants will be enrolled into 3 following cohorts: treatment-naive (TN...

What is the current status of trial NCT04008706?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 552 participants. The study started on 2019-09-17. Estimated completion is 2025-11-04.

What conditions does trial NCT04008706 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.

What interventions are being tested in trial NCT04008706?

The interventions under investigation include: Acalabrutinib (DRUG).

Who is sponsoring clinical trial NCT04008706?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04008706 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.