Chronic Lymphocytic LeukemiaPhase 2NCT02717611
A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
A Phase 2 study testing ACP-196 (acalabrutinib) in people with Chronic Lymphocytic Leukemia, run by Acerta Pharma BV at 23 sites in 6 countries.
Trial summary
A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- ACP-196 (acalabrutinib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 23 sitesin 6 countries
- Study dates
- 8 Mar 2016to 6 Jun 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age.
- Prior diagnosis of CLL
- Must have received ≥ 1 prior therapy for CLL
- Intolerant of ibrutinib
- Documented disease progression after stopping ibrutinib therapy as defined by the IWCLL 2008 criteria
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
- ECOG performance status of ≤ 2.
Who cannot join
- Ongoing AE attributed to ibrutinib therapy
- Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
- Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT- 199)
- 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.
- 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.
- 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.
Show all 15Show fewer
- Evidence of active Richter's transformation or any evidence of disease progression on ibrutinib therapy or any BTK inhibitor.
- CNS involvement by CLL or related Richter's transformation.
- Known history of human immunodeficiency virus (HIV), serologic status reflecting active hepatitis B or C infection, or any uncontrolled active systemic infection.
- Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
- History of stroke or intracranial hemorrhage within 2 months before the first dose of study drug.
- History of bleeding diathesis.
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
- Major surgical procedure within 28 days of first dose of study drug.
- Requires treatment with a strong CYP3A inhibitor
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
United States16 sites
Research Site
Chicago, Illinois, 60611
Research Site
Columbus, Ohio, 43210
Research Site
Concord, California, 94520
Research Site
Houston, Texas, 77030
Research Site
La Jolla, California, 92093
Research Site
Lake Success, New York, 11042
Research Site
Milwaukee, Wisconsin, 53226
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10021
Research Site
Palo Alto, California, 94304
Research Site
Seattle, Washington, 98108
Research Site
Seattle, Washington, 98122
Research Site
Sherman, Texas, USA
Research Site
Spokane, Washington, 99208
Research Site
Tucson, Arizona, 85704
Research Site
Washington D.C., District of Columbia, 20007
United Kingdom3 sites
Research Site
Bournemouth, BH7 7DW
Research Site
Leeds, LS9 7TF
Research Site
Manchester, M20 4BX
About this study
Official title: A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
Read the detailed description
A Multicenter, Open-Label, Phase 2 study evaluating the efficacy and safety of Acalabrutinib in subjects with relapsed/refractory CLL (N=60) who are intolerant of ibrutinib therapy.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- ACP-196 (acalabrutinib)
- Keywords
- Chronic Lymphocytic Leukemia, Ibrutinib Intolerant
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-196 (acalabrutinib)Drug
Also called Acalabrutinib
ACP-196 100 mg to be administered orally (PO) twice a day BID.
| Study group | Role | What they receive |
|---|---|---|
| ACP-196 (acalabrutinib) | Experimental | ACP-196 (acalabrutinib) 100 mg to be administered orally (PO) twice a day BID Receives: Drug: ACP-196 (acalabrutinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib)
The overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with relapsed / refractory CLL who are intolerant of ibrutinib therapy.
ORR is defined as the proportion of subjects achieving a best overall response (BOR) of either complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) at or before initiation of subsequent anticancer therapy. ORR will be analyzed per investigator's assessment.
Measured: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 4 years and 7 months). 1 cycle = 28 days
Secondary outcomes (4)
Progression-Free Survival
The progression-free survival of ACP-196 (acalabrutinib) in subjects with relapsed / refractory CLL who are intolerant of ibrutinib therapy.
PFS is calculated as date of disease progression or death (censoring date for censored subjects) - first dose date + 1.
Measured: From the date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years).
Duration of Response
The duration of response of ACP-196 (acalabrutinib) in subjects with relapsed / refractory CLL who are intolerant of ibrutinib therapy.
DOR is calculated as date of disease progression or death (censoring date for censored subjects) - date of achieving the first CR, CRi, nPR, or PR + 1.
Measured: From the date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
Time-to-Next Treatment
The time to next treatment of ACP-196 (acalabrutinib) in subjects with relapsed / refractory CLL who are intolerant of ibrutinib therapy.
TTNT is defined as the time from date of first acalabrutinib treatment to date of institution of subsequent anticancer therapy for CLL or death due to any cause, whichever comes first. Subjects who do not have the above specified events prior to the data cutoff date will be censored at the date of last visit. TTNT will be calculated as follows:
(Earlier date of institution of subsequent anticancer therapy for CLL or date of death due to any cause) - date of first dose + 1. For censored subjects, date of last visit will replace earlier date of use of subsequent anticancer therapy for CLL or date of death due to any cause in the calculation.
Measured: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
Overall Survival
The overall survival of ACP-319 (acalabrutinib) in subjects with relapsed/refractory CLL who are intolerant of ibrutinib therapy
Measured: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start8 Mar 2016
- Primary completion16 Oct 2020
- Study completion6 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Acerta Pharma BVThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Acerta Clinical Trials, Study director, 1-888-292-9613; acertamc@dlss.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717611
- Sponsor's protocol ID
- ACE-CL-208
- Other IDs
- 2015-005317-68, 2015
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2016
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Rogers KA, Thompson PA, Allan JN, Coleman M, Sharman JP, Cheson BD, Jones D, Izumi R, Frigault MM, Quah C, Raman RK, Patel P, Wang MH, Kipps TJ. Phase II study of acalabrutinib in ibrutinib-intolerant patients with relapsed/refractory chronic lymphocytic leukemia. Haematologica. 2021 Sep 1;106(9):2364-2373. doi: 10.3324/haematol.2020.272500.
PubMed 33730844Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. doi: 10.1182/blood-2016-05-716977. Epub 2016 Sep 6.
PubMed 27601462
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
- ClinicalTrials.gov ID
- NCT02717611
- Acronym / sponsor ID
- ACE-CL-208
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, Ibrutinib Intolerant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Acerta Pharma BVIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 6 Jun 2026 (estimated)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Posted 9 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
Detailed description
A Multicenter, Open-Label, Phase 2 study evaluating the efficacy and safety of Acalabrutinib in subjects with relapsed/refractory CLL (N=60) who are intolerant of ibrutinib therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACP-196 (acalabrutinib) | Experimental | Drug: ACP-196 (acalabrutinib)ACP-196 (acalabrutinib) 100 mg to be administered orally (PO) twice a day BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women ≥ 18 years of age.
- Prior diagnosis of CLL
- Must have received ≥ 1 prior therapy for CLL
- Intolerant of ibrutinib
- Documented disease progression after stopping ibrutinib therapy as defined by the IWCLL 2008 criteria
Key exclusion criteria (15 listed)
- Ongoing AE attributed to ibrutinib therapy
- Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
- Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT- 199)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP-196 (acalabrutinib)Also: AcalabrutinibACP-196 100 mg to be administered orally (PO) twice a day BID. | Drug | ACP-196 (acalabrutinib) |
Primary outcome
The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib)
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 4 years and 7 months). 1 cycle = 28 days
The overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with relapsed / refractory CLL who are intolerant of ibrutinib therapy. ORR is defined as the proportion of subjects achieving a best overall response (BOR) of either complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) at or before initiation of subsequent anticancer therapy. ORR will be analyzed per investigator's assessment.
4 secondary outcomes
Progression-Free Survival
Time frame: From the date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years).
Duration of Response
Time frame: From the date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
Time-to-Next Treatment
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
Overall Survival
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33730844Rogers KA, Thompson PA, Allan JN, Coleman M, Sharman JP, Cheson BD, Jones D, Izumi R, Frigault MM, Quah C, Raman RK, Patel P, Wang MH, Kipps TJ. Phase II study of acalabrutinib in ibrutinib-intolerant patients with relapsed/refractory chronic lymphocytic leukemia. Haematologica. 2021 Sep 1;106(9):2364-2373. doi: 10.3324/haematol.2020.272500.
- Derived from this study: PubMed 27601462Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. doi: 10.1182/blood-2016-05-716977. Epub 2016 Sep 6.
- redacted CSPLink provided by the sponsor.
- redacted CSR SynopsisLink provided by the sponsor.
- redacted SAPLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Acerta Clinical Trials study director
1-888-292-9613; acertamc@dlss.com
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACP-196 (acalabrutinib) in people with Chronic Lymphocytic Leukemia, run by Acerta Pharma BV at 23 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, United Kingdom, Belgium, France, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) (time frame: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 4 years and 7 months). 1 cycle = 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717611, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.