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New drug acalabrutinib takes on standard combo in untreated CLL

NCT ID NCT04075292

Disease control 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This Phase 3 trial compares the drug acalabrutinib to a combination of chlorambucil and rituximab in people with previously untreated chronic lymphocytic leukemia (CLL). The study includes 155 participants and measures how long the cancer stays under control (progression-free survival). The goal is to see if acalabrutinib works better or has fewer side effects than the current standard therapy.

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, acalabrutinib could offer a more effective and possibly safer first-line treatment option for people with chronic lymphocytic leukemia.
What could go wrong
This is an early-stage Phase 3 trial with only 155 participants. Results may not apply to all patients, and acalabrutinib may have side effects or not prove superior to the standard combination therapy.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

155 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Jan 2027

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: * Men and women: (a) ≥65 years of age OR (b) \>18 and \<65 years of age, provided that they meet at least one of the following criteria: (i) Creatinine clearance 30 to 69 mL/min using the Cockcroft-Gault equation (iwCLL guidelines) (ii) A score higher than 6 on the Cumulative Illness Rating Score-Geriatric (CIRS G) * ECOG performance status of 0, 1, or 2 * Diagnosis of CLL that meets published diagnostic criteria (Hallek 2018) * Active disease per IWCLL 2018 criteria that requires treatment * Adequate bone marrow function * Adequate renal and hepatic function Exclusion Criteria: * Known detected del(17p) or TP53 mutation * Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (eg, Richter's transformation, PLL, or diffuse large B cell lymphoma \[DLBCL\]), or central nervous system (CNS) involvement by leukemia * History of prior malignancy except for the following: (a) Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study (b) Other cancers not specified above which have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for ≥3 years without further treatment * Significant cardiovascular disease * Known history of infection with human immunodeficiency virus (HIV) * Serologic status reflecting active hepatitis B or C infection * Any active systemic infection (eg, bacterial, viral, or fungal infection) requiring systemic treatment * History of stroke or intracranial hemorrhage within 6 months before first dose of study drug * Major surgical procedure within 30 days of first dose of study drug * Any prior CLL-specific therapies * Corticosteroid use \>20 mg within 1 week before first dose of study drug, except as indicated for other medical conditions * Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists * For women only: breastfeeding 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.

Untreated chronic lymphocytic leukemia

Contacts and locations

Locations

  • Research Site

    Qingdao, 110016, China

  • Research Site

    Shanghai, 200025, China

  • Research Site

    Shanghai, 200040, China

  • Research Site

    Shanghai, 200050, China

  • Research Site

    Shenyang, 110001, China

  • Research Site

    Shijiazhuang, 050020, China

  • Research Site

    Suzhou, 215006, China

  • Research Site

    Taiyuan, 030001, China

  • Research Site

    Tianjin, 300020, China

  • Research Site

    Xuzhou, 221000, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Zhengzhou, 450052, China

  • Research Site

    Baguio City, 2600, Philippines

  • Research Site

    Cebu, 6000, Philippines

  • Research Site

    Davao City, 8000, Philippines

  • Research Site

    Makati, 1229, Philippines

  • Research Site

    Manila, 1000, Philippines

  • Research Site

    Quezon City, 1112, Philippines

  • Research Site

    Chiayi City, 613, Taiwan

  • Research Site

    Hualien City, 97002, Taiwan

  • Research Site

    Kaohsiung City, 833, Taiwan

  • Research Site

    Taichung, 404, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Chiang Mai, 50200, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Khon Kaen, 40002, Thailand

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Beijing, 100191, China

  • Research Site

    Changchun, 130021, China

  • Research Site

    Changsha, 410013, China

  • Research Site

    Changzhou, 272100, China

  • Research Site

    Guangzhou, 510100, China

  • Research Site

    Guangzhou, 510515, China

  • Research Site

    Guiyang, 550004, China

  • Research Site

    Hangzhou, 310003, China

  • Research Site

    Hefei, 230001, China

  • Research Site

    Hefei, 230031, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Nanjing, 210029, China

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