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New drug cocktail targets tough CLL

NCT ID NCT03328273

Disease control Sponsor: Acerta Pharma BV 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This early-phase trial tests two oral drugs—acalabrutinib and ceralasertib—in 12 people with high-risk chronic lymphocytic leukemia (CLL) that has stopped responding to other treatments. The main goal is to check safety and find the right dose. It is not yet known if the combination will shrink tumors or extend life.

What this could mean

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

Active substance
acalabrutinib and ceralasertib (two cancer drugs taken as pills)
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-treat CLL.
What could go wrong
This is a very early, small trial (12 people) focused on safety, not proof of effectiveness. The combination may not work or could cause serious side effects.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

12 people

The number who actually took part.

Started

Jan 2018

Expected to finish

Aug 2026

An estimate. End dates often move.

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.

Ages

18 to 130 years

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: * Diagnosis of relapsed or refractory CLL that meets published diagnostic criteria (International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] Hallek 2008) and supported/documented by medical records * Subjects must be Relapse/Refractory high risk CLL and have exhausted other therapeutic options according to local/regional standard of care * Must have received ≥1 prior therapy for treatment of their disease. Exclusion Criteria: * A diagnosis of ataxia telangiectasia * Any prior exposure to an ATR inhibitor or known hypersensitivity to an excipient of the product. * Known history of infection with human immunodeficiency virus (HIV). * A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196 (acalabrutinib) and/or Ceralasertib * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \> 480 msec. * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. * Requirement of treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study. * Breast feeding or pregnant

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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

    Krakow, 30-510, Poland

  • Research Site

    Lodz, 93-510, Poland

  • Research Site

    Birmingham, B9 5SS, United Kingdom

  • Research Site

    Bournemouth, BH7 7DW, United Kingdom

  • Research Site

    Cardiff, CF14 4XW, United Kingdom

  • Research Site

    Leeds, LS9 7TF, United Kingdom

  • Research Site

    London, NW1 2PG, United Kingdom

  • Research Site

    London, SE5 9RS, United Kingdom

  • Research Site

    Nottingham, NG5 1PB, United Kingdom

  • Research Site

    Oxford, OX3 7LJ, United Kingdom

  • Research Site

    Southampton, SO16 6YD, United Kingdom

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