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NCT06651970 · ClinicalTrials.gov registry record · Phase 4

Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure

A Phase 4 study of Heart Failure and Chronic Lymphocytic Leukaemia, sponsored by AstraZeneca.

Recruiting
Registry status
Phase 4
Development phase
60
Enrollment target
20
Study locations

NCT06651970 is a Phase 4 study of Heart Failure and Chronic Lymphocytic Leukaemia that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 60 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 4 states.

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The verdict

NCT06651970, a Phase 4 study of Heart Failure and Chronic Lymphocytic Leukaemia, is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 4
Development phase
60 participants
Enrollment target
20
Study locations

Study Summary

This will be a global Phase IV, open-label, randomised study to evaluate the safety and tolerability of acalabrutinib (monotherapy, 100 mg orally \[po\], twice daily \[bd\]) compared to investigator's choice of treatment, in patients with CLL (TN or R/R) and moderate to severe cardiac impairment. All patients will have cardiac impairment as defined by LVEF of \< 50%. Randomisation will be stratified by LVEF \> 40% vs ≤ 40% to stratify for moderate and severe cardiac impairment, which for this study are defined as follows: Severe cardiac impairment: in those with LVEF ≤ 40% Moderate cardiac impairment: in those with LVEF \> 40% to \< 50%. The study is planned to take place in approximately 20 centres globally. The study will be conducted in centres that have established close collaboration between the Haematology and Cardiology divisions, preferably with a cardio-oncologist on the team. An IDMC will be responsible for making recommendations for study continuation.

Conditions Studied

Heart Failure Chronic Lymphocytic Leukaemia

Interventions

  • DRUG Acalabrutinib
  • OTHER Investigator's choice of treatment

Study Locations (20)

Other

  • Research Site - Brno
  • Research Site - Hradec Králové
  • Research Site - Prague
  • Research Site - Cagliari
  • Research Site - Florence
  • Research Site - Milan
  • Research Site - Milan
  • Research Site - Pavia
  • Research Site - Perugia
  • Research Site - Krakow
  • Research Site - Poznan
  • Research Site - Barcelona
  • Research Site - Madrid
  • Research Site - Seville
  • Research Site - Bournemouth
  • Research Site - Oxford
  • Research Site - Plymouth

North Carolina

  • Research Site - Charlotte

Ohio

  • Research Site - Columbus

Pennsylvania

  • Research Site - Philadelphia

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-02-04
Est. Completion 2030-08-16
Phase Phase 4

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06651970

The ClinicalTrials.gov registry entry for NCT06651970 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Acalabrutinib is the first listed.

NCT06651970 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Other, North Carolina, Ohio.

Frequently Asked Questions

What is clinical trial NCT06651970 about?

NCT06651970 is a clinical study titled "Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure". This will be a global Phase IV, open-label, randomised study to evaluate the safety and tolerability of acalabrutinib (monotherapy, 100 mg orally \[po\], twice daily \[bd\]) compared to investigator's choice of treatment, in patients with CLL (TN or R/R) and moderate to severe cardiac impairment. Al...

What is the current status of trial NCT06651970?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2025-02-04. Estimated completion is 2030-08-16.

What conditions does trial NCT06651970 study?

This clinical trial studies the following conditions: Heart Failure, Chronic Lymphocytic Leukaemia.

What interventions are being tested in trial NCT06651970?

The interventions under investigation include: Acalabrutinib (DRUG), Investigator's choice of treatment (OTHER).

Who is sponsoring clinical trial NCT06651970?

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

Where is trial NCT06651970 being conducted?

This trial has 20 study locations across North Carolina, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.