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New study checks bleeding risk when CLL drug meets blood thinners

NCT ID NCT05517265

Disease control Sponsor: iOMEDICO AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study observed 45 people with chronic lymphocytic leukemia (CLL) who were taking the drug acalabrutinib (Calquence) along with a direct oral anticoagulant (DOAC), a type of blood thinner. The main goal was to see how many patients had serious bleeding events while on this combination. The study did not test a new treatment but aimed to gather real-world safety data to help doctors manage bleeding risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

45 people

The number who actually took part.

Started

Oct 2022

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients with CLL receiving acalabrutinib (+/- obinutuzumab) and co-medication with DOAC.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 years of age or older * Patients with chronic lymphocytic leukemia (CLL) and decision for treatment with acalabrutinib (+/- obinutuzumab) according to current SmPC as assessed by the treating physician or already started treatment with acalabrutinib (+/- obinutuzumab) according to current SmPC no longer than 6 weeks ago * Other concomitant disease resulting in medical need of or already under treatment with direct oral anticoagulant (DOAC) treatment with edoxaban (Lixiana®) or rivaroxaban (Xarelto®) or dabigatran (Pradaxa®) or apixaban (Eliquis®) according to the respective current SmPC. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Signed, written informed consent. Exclusion Criteria: * Combination of acalabrutinib with other substances than obinutuzumab for CLL treatment * Participation in an interventional clinical trial with acalabrutinib

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CLL

Contacts and locations

Locations

  • Prof. Dr. Fenchel & Dr. Winkler MVZ Träger GbR

    Saalfeld, Thuringia, 07318, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.