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New targeted drug shows promise for Hard-to-Treat leukemia

NCT ID NCT02337829

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 22, 2026 · Updated 2 times

Summary

This study tested a drug called acalabrutinib in 48 adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had a specific high-risk genetic change (deletion 17p). Some participants had already tried other treatments, while others were newly diagnosed. The goal was to see how well the drug shrank or controlled the cancer by blocking a key protein (BTK) that helps cancer cells grow. Results were measured using standard response criteria.

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

48 people

The number who actually took part.

Started

Jan 2015

Finished

Oct 2025

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: * Men and women 18 years of age and older with histologically confirmed disease. * Active disease as defined by at least one of the following (IWCLL consensus criteria): * Weight loss ≥10% within the previous 6 months * Extreme fatigue * Fevers of greater than 100.5ºF for ≥2 weeks without evidence of infection * Night sweats for more than one month without evidence of infection * Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia * Massive or progressive splenomegaly * Massive nodes or clusters or progressive lymphadenopathy * Progressive lymphocytosis with an increase of \>50% over a 2 month period, or an anticipated doubling time of less than 6 months * Compensated autoimmune hemolysis * Relapsed/Refractory CLL or treatment naïve CLL patients with 17p deletion, TP53 mutation, or NOTCH1 mutation * Agreement to use acceptable methods of contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear or beget children. * Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty and serial biopsies. * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations). Exclusion Criteria: * Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or investigational products in the last 4 weeks. * Richter's transformation. Autoimmune hemolytic anemia or thrombocytopenia requiring steroid therapy. Impaired hepatic function

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chromosome 17p deletion leukemia lymphoma Recurrence

As listed by the trial registrant

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

Chronic lymphocytic leukemia Small lymphocytic lymphoma

Contacts and locations

Locations

  • Research Site

    Bethesda, Maryland, 20892, United States

More trials for these conditions

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