Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

Frequency and time to discontinuation of any study treatment due to worsening in cardiovascular function or cardiovascular AEs.

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
AstraZeneca

1,285 total trials

What NCT06651970 shows while recruiting

NCT06651970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower).

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 names 20 study sites across 4 states, led by 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.

Learn More About Clinical Trials

Similar trials for Heart Failure

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06651970's enrollment target sits among peer trials

60 254th of 397 higher than 131 of 397 other Heart Failure trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00576069 · 60 participants

    Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma

  • NCT01297400 · 60 participants · Phase 2

    Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns

  • NCT01734122 · 60 participants

    Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor

  • NCT01804634 · 60 participants · Phase 2

    Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT06651970

Source: ClinicalTrials.gov NCT06651970, the US trial registry maintained by the National Library of Medicine. NCT06651970 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.