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New combo aims to tackle returning blood cancer

NCT ID NCT07024706

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 3 times

Summary

This phase 2 trial tests a combination of two drugs, acalabrutinib and venetoclax, in 80 people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose cancer has returned after initial treatment. Participants must have responded well to their first therapy and stayed in remission for at least two years. The study aims to see if this finite-duration combo can effectively control the disease again.

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 venetoclax
What this could lead to
If successful, this could offer a new treatment option for people with CLL/SLL whose cancer returns after initial therapy, potentially extending remission without continuous medication.
What could go wrong
This is a small, early-phase study (80 people) with no results yet. The treatment may not work as well as hoped, and side effects like low blood counts or infections are possible.

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

About 80 people

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

Started

Jun 2026

Expected to finish

Mar 2033

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.

Main Inclusion Criteria: 1. Participant must be ≥ 18 years at the time of signing informed consent. 2. Diagnosis of CLL/SLL according to iwCLL guidelines 2018 (Hallek et al. 2018) 3. Participants must have received first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ PR (i.e., CR, CRi, nPR, or PR) with a minimum of 2 years since the end of the prior 1L treatment. 4. The following data must be available or at least the appropriate samples drawn/acquired prior to dosing: 1. IGHV (mutated vs. unmutated) 2. del(17p) (present or absent) 3. TP53 mutation (present or absent) 5. ECOG performance status 0, 1 or 2 6. Adequate organ and bone marrow (BM) function. Main Exclusion Criteria: 1. Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study. 2. Significant cardiovascular or cerebrovascular disease. 3. Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease). 4. Child-Pugh B/C liver cirrhosis. 5. History of prior or current malignancy. 6. HIV positive 7. History of progressive multifocal leukoencephalopathy (PML). 8. Active hepatitis B or C infection: 9. Corticosteroid use \> 20 mg within 1 week before the first dose of study intervention. 10. History of hypersensitivity or anaphylaxis to study intervention(s). 11. Requires treatment with a strong CYP3A4 inhibitor/inducer. 12. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists. 13. Major surgical procedure within 30 days of the first dose of study intervention.

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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 (CLL) Small lymphocytic lymphoma (SLL)

How to take part

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

  1. The places running it

    30 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Research Site

    WITHDRAWN

    Charlotte, North Carolina, 28204, United States

  • Research Site

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Research Site

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Research Site

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Research Site

    RECRUITING

    Horn, 3580, Austria

  • Research Site

    NOT_YET_RECRUITING

    Goiânia, 74605-020, Brazil

  • Research Site

    NOT_YET_RECRUITING

    Porto Alegre, 90035-903, Brazil

  • Research Site

    NOT_YET_RECRUITING

    Porto Alegre, 90110-270, Brazil

  • Research Site

    NOT_YET_RECRUITING

    São Paulo, 01246-000, Brazil

  • Research Site

    NOT_YET_RECRUITING

    São Paulo, 1409, Brazil

  • Research Site

    NOT_YET_RECRUITING

    Brno, 625 00, Czechia

  • Research Site

    NOT_YET_RECRUITING

    Hradec Kralova, 50005, Czechia

  • Research Site

    NOT_YET_RECRUITING

    Ostrava, 708 502, Czechia

  • Research Site

    RECRUITING

    Dublin, 7, Ireland

  • Research Site

    RECRUITING

    Dublin, D08 NHY1, Ireland

  • Research Site

    RECRUITING

    Meldola, 47014, Italy

  • Research Site

    WITHDRAWN

    Milan, 20132, Italy

  • Research Site

    NOT_YET_RECRUITING

    Milan, 20162, Italy

  • Research Site

    RECRUITING

    Padua, 35128, Italy

  • Research Site

    RECRUITING

    Ravenna, 48121, Italy

  • Research Site

    WITHDRAWN

    Rome, 00168, Italy

  • Research Site

    WITHDRAWN

    Torino, 10126, Italy

  • Research Site

    NOT_YET_RECRUITING

    Bydgoszcz, 85-168, Poland

  • Research Site

    WITHDRAWN

    Krakow, 30-727, Poland

  • Research Site

    WITHDRAWN

    Lodz, 93-513, Poland

  • Research Site

    NOT_YET_RECRUITING

    Lublin, 20-090, Poland

  • Research Site

    NOT_YET_RECRUITING

    Warsaw, 02-172, Poland

  • Research Site

    NOT_YET_RECRUITING

    Warsaw, 02-776, Poland

  • Research Site

    RECRUITING

    Barcelona, 08041, Spain

  • Research Site

    NOT_YET_RECRUITING

    Barcelona, 8035, Spain

  • Research Site

    RECRUITING

    Granada, 18014, Spain

  • Research Site

    RECRUITING

    Madrid, 28031, Spain

  • Research Site

    RECRUITING

    Madrid, 28034, Spain

  • Research Site

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

  • Research Site

    RECRUITING

    Majadahonda, 28222, Spain

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