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AzTrials

Chronic Lymphocytic LeukemiaPhase 2NCT02337829

Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL

A Phase 2 study testing Acalabrutinib (Arm A) and Acalabrutinib (Arm B) in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Acerta Pharma BV at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Acalabrutinib (Arm A) and Acalabrutinib (Arm B)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
12 Jan 2015to 31 Oct 2025
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 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
Show all 15Show fewer
  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Site

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Phase II Study Using ACP-196 (Acalabrutinib) in Patients With Relapsed/Refractory and Treatment-naïve Deletion 17p CLL/SLL: Pharmacodynamic Assessment of BTK Inhibition and Antitumor Response.

This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Read the detailed description

To investigate the safety and efficacy of acalabrutinib for patients with CLL/SLL that have relapsed/refractory disease or treatment naive deletion 17p.

Being tested
Acalabrutinib (Arm A), Acalabrutinib (Arm B)
Keywords
Relapsed/refractory CLL, Btk, Leukemia, Lymphocytic, Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), ACP-196, Acalabrutinib, Treatment naive CLL, 17p deletion, TP53 mutation, NOTCH1 mutation
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence, Leukemia, Lymphoma, Chromosome 17 deletion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acalabrutinib (Arm A)Drug

    Also called ACP-196

    • A1a) acalabrutinib, dose A daily: biopsy (T) schedule W;
    • A1b) acalabrutinib, dose A daily: biopsy (T) schedule V.
    • A2a) acalabrutinib, dose B q 12 hours: biopsy (T) schedule Y;
    • A2b) acalabrutinib, dose B q 12 hours; biopsy (T) schedule Z

  • Acalabrutinib (Arm B)Drug

    Also called ACP-196

    B1c) acalabrutinib, dose A daily: biopsy (U) schedule W;

    • B2c) acalabrutinib, dose B q12 hours: biopsy (U)) schedule Y.
Study groups in NCT02337829
Study groupRoleWhat they receive
Arm AExperimentalSubjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily.
Receives: Drug: Acalabrutinib (Arm A); Drug: Acalabrutinib (Arm B)
Arm BExperimentalSubjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily.
Receives: Drug: Acalabrutinib (Arm A); Drug: Acalabrutinib (Arm B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Based on Overall Response Rate

    The best response to treatment was determined according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria incorporating 2012 and 2013 clarifications pertaining to subjects treated with kinase inhibitors. Overall response rate (ORR) was the proportion of subjects who achieved complete response (CR), CR with incomplete marrow recovery (CRi), or partial response (PR) while on treatment before the initiation of new anti-cancer therapy or stem cell transplant.

    Measured: Cycle 1 (28 Days) to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2015 (estimated)
  2. Study start12 Jan 2015
  3. Primary completion26 Jun 2020
  4. Study completion31 Oct 2025

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02337829
Sponsor's protocol ID
15-H-0016
Status last verified
Jul 2026
First submitted
19 Nov 2014
Last updated
21 Jul 2026
Data monitoring committee
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

  • Alsadhan A, Chen J, Gaglione EM, Underbayev C, Tuma PL, Tian X, Freeman LA, Baskar S, Nierman P, Soto S, Itsara A, Ahn IE, Sun C, Bibikova E, Hartmann TN, Mhibik M, Wiestner A. CD49d Expression Identifies a Biologically Distinct Subtype of Chronic Lymphocytic Leukemia with Inferior Progression-Free Survival on BTK Inhibitor Therapy. Clin Cancer Res. 2023 Sep 15;29(18):3612-3621. doi: 10.1158/1078-0432.CCR-22-3217.

    PubMed 37227160

  • Cyr MG, Mhibik M, Qi J, Peng H, Chang J, Gaglione EM, Eik D, Herrick J, Venables T, Novick SJ, Courouble VV, Griffin PR, Wiestner A, Rader C. Patient-derived Siglec-6-targeting antibodies engineered for T-cell recruitment have potential therapeutic utility in chronic lymphocytic leukemia. J Immunother Cancer. 2022 Nov;10(11):e004850. doi: 10.1136/jitc-2022-004850.

    PubMed 36442911

  • Sun C, Nierman P, Kendall EK, Cheung J, Gulrajani M, Herman SEM, Pleyer C, Ahn IE, Stetler-Stevenson M, Yuan CM, Maric I, Gaglione EM, Harris HM, Pittaluga S, Wang MH, Patel P, Farooqui MZH, Izumi R, Hamdy A, Covey T, Wiestner A. Clinical and biological implications of target occupancy in CLL treated with the BTK inhibitor acalabrutinib. Blood. 2020 Jul 2;136(1):93-105. doi: 10.1182/blood.2019003715.

    PubMed 32202637

  • Alsadhan A, Cheung J, Gulrajani M, Gaglione EM, Nierman P, Hamdy A, Izumi R, Bibikova E, Patel P, Sun C, Covey T, Herman SEM, Wiestner A. Pharmacodynamic Analysis of BTK Inhibition in Patients with Chronic Lymphocytic Leukemia Treated with Acalabrutinib. Clin Cancer Res. 2020 Jun 15;26(12):2800-2809. doi: 10.1158/1078-0432.CCR-19-3505. Epub 2020 Feb 13.

    PubMed 32054731

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acalabrutinib (Arm A) and Acalabrutinib (Arm B) in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Acerta Pharma BV at 1 site in United States.

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 15 inclusion and 2 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: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 18 Aug 2021). 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?

Response Based on Overall Response Rate (time frame: Cycle 1 (28 Days) to 6 months). 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 NCT02337829, which also lists 4 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 21 Jul 2026.

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