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New hope for leukemia patients who Can't tolerate standard treatment

NCT ID NCT02717611

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called ACP-196 (acalabrutinib) in 60 adults with chronic lymphocytic leukemia (CLL) whose cancer returned or didn't respond to treatment and who had to stop ibrutinib because of side effects. The main goal is to see how many patients have their tumors shrink or disappear. Participants take the drug by mouth, and researchers track how long the benefits last and any 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

Mar 2016

Expected to finish

Jun 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 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. Men and women ≥ 18 years of age. 2. Prior diagnosis of CLL 3. Must have received ≥ 1 prior therapy for CLL 4. Intolerant of ibrutinib 5. Documented disease progression after stopping ibrutinib therapy as defined by the IWCLL 2008 criteria 6. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty. 7. ECOG performance status of ≤ 2. Exclusion Criteria: 1. Ongoing AE attributed to ibrutinib therapy 2. Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial. 3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT- 199) 4. Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥ 2 years. 5. Significant cardiovascular disease such as uncontrolled or symptomatic untreated 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 QTc \> 480 msec at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 6. Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. 7. Evidence of active Richter's transformation or any evidence of disease progression on ibrutinib therapy or any BTK inhibitor. 8. CNS involvement by CLL or related Richter's transformation. 9. Known history of human immunodeficiency virus (HIV), serologic status reflecting active hepatitis B or C infection, or any uncontrolled active systemic infection. 10. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP) 11. History of stroke or intracranial hemorrhage within 2 months before the first dose of study drug. 12. History of bleeding diathesis. 13. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening. 14. Major surgical procedure within 28 days of first dose of study drug. 15. Requires treatment with a strong CYP3A inhibitor

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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

    Tucson, Arizona, 85704, United States

  • Research Site

    Concord, California, 94520, United States

  • Research Site

    La Jolla, California, 92093, United States

  • Research Site

    Palo Alto, California, 94304, United States

  • Research Site

    Washington D.C., District of Columbia, 20007, United States

  • Research Site

    Chicago, Illinois, 60611, United States

  • Research Site

    Lake Success, New York, 11042, United States

  • Research Site

    New York, New York, 10021, United States

  • Research Site

    Columbus, Ohio, 43210, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Sherman, Texas, USA, United States

  • Research Site

    Seattle, Washington, 98108, United States

  • Research Site

    Seattle, Washington, 98122, United States

  • Research Site

    Spokane, Washington, 99208, United States

  • Research Site

    Milwaukee, Wisconsin, 53226, United States

  • Research Site

    Bruges, 8000, Belgium

  • Research Site

    Bordeaux, 33076, FR, France

  • Research Site

    Haifa, 31000, Israel

  • Research Site

    Madrid, 28006, Spain

  • Research Site

    Bournemouth, BH7 7DW, United Kingdom

  • Research Site

    Leeds, LS9 7TF, United Kingdom

  • Research Site

    Manchester, M20 4BX, United Kingdom

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