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Russian study to monitor Real-World use of acalabrutinib in CLL patients

NCT ID NCT04746950

Knowledge-focused Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 1 time

Summary

This observational study will follow about 90 adults with chronic lymphocytic leukemia (CLL) in Russia who are prescribed acalabrutinib as part of their routine care. Researchers will collect data from medical records to see how long patients stay free of disease progression and what side effects occur. No extra tests or treatments are involved—just watching what happens in real-world practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acalabrutinib
What this could lead to
If successful, this study could provide real-world evidence on how well acalabrutinib works and its side effects in routine clinical practice for CLL patients in Russia.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection and local practices. It cannot prove cause and effect.

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

90 people

The number who actually took part.

Started

Feb 2021

Finished

Feb 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

The Enrolled set will be represented by eligible patients who have signed an informed consent form to participate in the study. It is estimated that approximately 200 patients will be enrolled in the study. Study population will consist of adult patients with diagnosed CLL ≥ 18 years old (treatment naïve (TN) or relapsed/refractory (R/R)) for whom acalabrutinib in monotherapy was prescribed by treating physician decision no more than 4 weeks ago before screening.

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: * Age ≥18 years * Confirmed diagnosis of CLL * Patient started treatment with monotherapy acalabrutinib (prescribed by physician decision no more than 4 weeks ago before screening) * Capability of providing written Informed Consent Form Exclusion Criteria: * Patients not corresponded to inclusion criteria * Pregnancy * Lactation * Patients included in open-label trials * Previous Bruton tyrosine kinase inhibitors (BTKI) treatment

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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.

Chronic lymphocytic leukemia

Contacts and locations

Locations

  • Research Site

    Ufa, Bashkortostan Republic, 450054, Russia

  • Research Site

    Kaliningrad, Kaliningrad Oblast, Russia

  • Research Site

    Khabarovsk, Khabarovskiy Kray, 680009, Russia

  • Research Site

    Syktyvkar, Komi, Russia

  • Research Site

    Krasnoyarsk, Krasnoyarsk Region, 660022, Russia

  • Research Site

    Saint Petersburg, Leningradskaya Oblast', 198205, Russia

  • Research Site

    Moscow, Moscow Oblast, 125284, Russia

  • Research Site

    Moscow, Moscow Oblast, 129110, Russia

  • Research Site

    Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

  • Research Site

    Novosibirsk, Novosibirsk Oblast, 630091, Russia

  • Research Site

    Yakutsk, Sakha Republic, 677008, Russia

  • Research Site

    Saratov, Saratov Oblast, 410028, Russia

  • Research Site

    Kaliningrad, Russia

  • Research Site

    Nizhny Novgorod, Russia

  • Research Site

    Tomsk, Russia

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