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Real-World data may reveal how acalabrutinib performs in chinese blood cancer patients

NCT ID NCT06767891

Knowledge-focused Sponsor: Ruijin Hospital 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This observational study tracks about 160 Chinese adults with mantle cell lymphoma (MCL) or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who take acalabrutinib as part of their normal care. Researchers will record how the drug is used, including doses and combinations, and monitor safety and outcomes like survival and response. The goal is to see if the drug's benefits seen in clinical trials hold up 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
This study could show how well acalabrutinib works in everyday Chinese patients, helping doctors tailor treatment for MCL and CLL/SLL.
What could go wrong
As an observational study, it does not test a new treatment but observes existing use, so results may be limited by real-world variability and lack of a control group.

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

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Chinese patients with MCL (with ≥1 prior therapy) or CLL/SLL (treatment-naïve or with ≥1 prior therapy), treated with acotinib according to the local prescribing label, in routine clinical practice

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: * 1: Patients should be ≥18 years old at diagnosis * 2: Diagnosed as MCL who have received at least one prior therapy, OR diagnosed as CLL/SLL who are treatment-naïve or have received at least one prior therapy (per the local prescribing label for acalabrutinib) * 3: Eligible for acalabrutinib treatment assessed by investigators (physician's evaluation) in clinical practice * 4: Patient/legal guardian must be able to read, understand, and sign the informed consent form (ICF) Exclusion Criteria: * 1: Ineligible for acalabrutinib treatment assessed by investigators (physician's evaluation) * 2: Progression after accepting other BTKi treatment before use of acalabrutinib * 3: Concurrent participation in another interventional clinical study * 4: Females of childbearing potential must practice highly effective contraception during treatment of acalabrutinib, and for at least 1 week after the last dose of acalabrutinib, and have a negative urine or serum pregnancy test ≤ 7 days before the first dose of study drug(s). * 5: No requirement to use contraception for male subjects treated with acalabrutinib. a. A sterile male is considered a highly effective contraception method for female patients. b. Males with known "low sperm counts" (consistent with "sub-fertility") are not to be considered sterile for purposes of this study.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma mantle cell lymphoma

As listed by the trial registrant

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

Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) Mantle cell lymphoma (MCL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

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