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Compound · clinical trials

Acalabrutinib clinical trials

Also listed in trial records as ACP-196
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 31 trials in our USA, UK, China, Ireland and India registers that name Acalabrutinib as an intervention. Synced 25 Sep 2026
31Current trials
13Recruiting now
10Lead sponsors
5Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Acalabrutinib is named as an intervention in 31 current clinical trials in our USA, UK, China, Ireland and India registers. 13 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Acerta Pharma BV (15). The most-studied condition is Chronic Lymphocytic Leukemia.

Acalabrutinib also has an approved-drug profile on this site (FDA label data): Calquence (Acalabrutinib) →

Trials by status

  • Recruiting1342%
  • Active, closed1858%

Trials by phase

  • Phase 31135%
  • Phase 2826%
  • Phase 1/2619%
  • Phase 1310%
  • Observational13%
  • Phase 413%
  • Not applicable13%
01

Clinical trials of Acalabrutinib

31 trials
StudyPhaseStatusLead sponsorRegisters
Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
NCT06651970 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukaemia, Moderate to Severe Cardiac Impairment
Phase 4 Recruiting AstraZeneca UK, USA
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
NCT06136559 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Phase 3 Recruiting Merck Sharp & Dohme LLC UK, USA, China
A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
NCT06428019 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia
Phase 3 Recruiting AbbVie UK, USA, China
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
NCT07277231 · Chronic Lymphocytic Leukemia
Phase 3 Recruiting BeOne Medicines UK, USA, China
Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
NCT05952024 · Diffuse Large B-Cell Lymphoma
Phase 2 Recruiting AstraZeneca USA
Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma
NCT06846489 · ClinicalTrials.gov ↗ · Mantle Cell Lymphoma (MCL)
Phase 2 Recruiting Sun Yat-sen University China
Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy
NCT06958705 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
Phase 2 Recruiting The First Affiliated Hospital with Nanjing Medical University China
Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ยฑ Obinutuzumab
NCT07024706 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
Phase 2 Recruiting AstraZeneca Ireland, USA
A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
NCT03571568 · ClinicalTrials.gov ↗ · Indolent B-Cell Non-Hodgkin Lymphoma
Phase 1/2 Recruiting BioInvent International AB USA
Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL
NCT04502394 · ClinicalTrials.gov ↗ · Diffuse Large B Cell Lymphoma, Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
Phase 1/2 Recruiting Kartos Therapeutics, Inc. UK, USA
A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
NCT06564038 · Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma, Mantle-cell Lymphoma
Phase 1/2 Recruiting AstraZeneca UK, USA, China
Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom
NCT05557695 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia, CLL
Observational Recruiting AstraZeneca UK
A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL
NCT05950997 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia
Not applicable Recruiting The First Affiliated Hospital with Nanjing Medical University China
Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naรฏve CLL
NCT02475681 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia
Phase 3 Active, closed Acerta Pharma BV UK, USA
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
NCT02477696 · Chronic Lymphocytic Leukemia
Phase 3 Active, closed Acerta Pharma BV UK, USA
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
NCT02970318 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia
Phase 3 Active, closed Acerta Pharma BV UK, USA
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL
NCT02972840 · ClinicalTrials.gov ↗ · Lymphoma, Mantle Cell
Phase 3 Active, closed Acerta Pharma BV USA, China
Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
NCT03836261 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia
Phase 3 Active, closed Acerta Pharma BV UK, USA, China
A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)
NCT04529772 · ClinicalTrials.gov ↗ · Diffuse Large B-Cell Lymphoma
Phase 3 Active, closed Acerta Pharma BV USA, India, China
Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
NCT04662255 · ClinicalTrials.gov ↗ · Lymphoma, Mantle-Cell
Phase 3 Active, closed Loxo Oncology, Inc. UK, USA, China
A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT05057494 · Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Phase 3 Active, closed AstraZeneca USA
An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenstrรถm Macroglobulinemia
NCT02180724 · ClinicalTrials.gov ↗ · Waldenstrรถm Macroglobulinemia (WM)
Phase 2 Active, closed Acerta Pharma BV UK, USA
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
NCT02213926 · ClinicalTrials.gov ↗ · Mantle Cell Lymphoma (MCL)
Phase 2 Active, closed Acerta Pharma BV UK, USA
A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
NCT02717611 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia
Phase 2 Active, closed Acerta Pharma BV UK, USA
A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naรฏve Mantle Cell Lymphoma
NCT05951959 · Mantle Cell Lymphoma (MCL)
Phase 2 Active, closed AstraZeneca UK, USA
ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia
NCT02029443 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome
Phase 1/2 Active, closed Acerta Pharma BV UK, USA
Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
NCT02180711 · ClinicalTrials.gov ↗ · Non Hodgkin Lymphoma
Phase 1/2 Active, closed Acerta Pharma BV USA
A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)
NCT02586857 · ClinicalTrials.gov ↗ · Glioblastoma Multiforme
Phase 1/2 Active, closed Acerta Pharma BV USA
Acalabrutinib in Combination With ACP-319, for Treatment of Chronic Lymphocytic Leukemia
NCT02157324 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia
Phase 1 Active, closed Acerta Pharma BV USA
A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
NCT02717624 · ClinicalTrials.gov ↗ · Mantle Cell Lymphoma (MCL)
Phase 1 Active, closed Acerta Pharma BV USA
A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
NCT03328273 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia
Phase 1 Active, closed Acerta Pharma BV UK

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Acalabrutinib across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

2 single-substance products containing Acalabrutinib on the HPRA medicines list.

All 2 Irish products →

Supply shortages

No entry for Acalabrutinib in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Acalabrutinib

22 conditions
Chronic Lymphocytic Leukemia13Mantle Cell Lymphoma (MCL)4Small Lymphocytic Lymphoma3Chronic Lymphocytic Leukaemia2Non Hodgkin Lymphoma2Diffuse Large B-Cell Lymphoma2Chronic Lymphocytic Leukemia (CLL)1Small Lymphocytic Lymphoma (SLL)1Mantle-cell Lymphoma1Large B-cell Lymphoma1Waldenstrรถm Macroglobulinemia (WM)1Lymphoma, Mantle-Cell1
All 22 conditions
Condition (as registered)Trials
Chronic Lymphocytic Leukemia13
Mantle Cell Lymphoma (MCL)4
Small Lymphocytic Lymphoma3
Chronic Lymphocytic Leukaemia2
Non Hodgkin Lymphoma2
Diffuse Large B-Cell Lymphoma2
Chronic Lymphocytic Leukemia (CLL)1
Small Lymphocytic Lymphoma (SLL)1
Mantle-cell Lymphoma1
Large B-cell Lymphoma1
Waldenstrรถm Macroglobulinemia (WM)1
Lymphoma, Mantle-Cell1
Chronic Lymphocytic Leukemia, CLL1
Diffuse Large B Cell Lymphoma1
Moderate to Severe Cardiac Impairment1
Richter's Syndrome1
Prolymphocytic Leukemia1
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma1
Indolent B-Cell Non-Hodgkin Lymphoma1
Lymphoma, Mantle Cell1
Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)1
Glioblastoma Multiforme1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Acerta Pharma BV15
AstraZeneca7
The First Affiliated Hospital with Nanjing Medical University2
Loxo Oncology, Inc.1
Kartos Therapeutics, Inc.1
Merck Sharp & Dohme LLC1
BeOne Medicines1
AbbVie1
BioInvent International AB1
Sun Yat-sen University1
05

By country register

RegisterTrialsRecruiting
Clinical trials in USA269
Clinical trials in UK187
Clinical trials in China117
Clinical trials in Ireland11
Clinical trials in India10

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Acalabrutinib trials

How many clinical trials are testing Acalabrutinib?

31 current trials in our USA, UK, China, Ireland and India registers name Acalabrutinib (also registered as ACP-196) as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Acalabrutinib trials recruiting patients?

Yes. 13 of the 31 trials are recruiting: 9 with sites in USA, 7 with sites in UK, 7 with sites in China and 1 with sites in Ireland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Acalabrutinib clinical trials?

Acerta Pharma BV (15), AstraZeneca (7), The First Affiliated Hospital with Nanjing Medical University (2) and Loxo Oncology, Inc (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Is Acalabrutinib licensed in Ireland?

Yes. The HPRA medicines list includes 2 single-substance products containing Acalabrutinib, for example Calquence 100 mg hard capsules (AstraZeneca AB). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Acalabrutinib shortage?

Not in the lists we track: Acalabrutinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Acalabrutinib works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Acalabrutinib works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Acalabrutinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.