An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia
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ClinicalTrials.gov Identifier: NCT02180724 |
Recruitment Status :
Active, not recruiting
First Posted : July 3, 2014
Last Update Posted : February 1, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Waldenström Macroglobulinemia (WM) | Drug: Acalabrutinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 106 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia |
Actual Study Start Date : | July 2014 |
Actual Primary Completion Date : | February 2018 |
Estimated Study Completion Date : | August 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Acalabrutinib Regimen 1
Acalabrutinib Regimen 1
|
Drug: Acalabrutinib |
- Overall response rate (ORR) of acalabrutinib in subjects with previously treated WM [ Time Frame: Participants will be followed every 28 days or until progression of disease or start of another anti-cancer treatment for at least 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women ≥ 18 years of age
- A confirmed diagnosis of WM, which requires treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Exclusion Criteria:
- A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk.
- Significant cardiovascular disease such as uncontrolled or symptomatic 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 LVEF < 40%
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- Breast feeding or pregnant.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180724
United States, District of Columbia | |
Washington, District of Columbia, United States | |
United States, New York | |
New York, New York, United States | |
United States, Texas | |
Houston, Texas, United States | |
Netherlands | |
Amsterdam, Netherlands | |
United Kingdom | |
Leicester, United Kingdom |
Study Director: | Acerta Clinical Trials | 1-888-292-9613; acertamc@dlss.com |
Responsible Party: | Acerta Pharma BV |
ClinicalTrials.gov Identifier: | NCT02180724 History of Changes |
Other Study ID Numbers: |
ACE-WM-001 |
First Posted: | July 3, 2014 Key Record Dates |
Last Update Posted: | February 1, 2019 |
Last Verified: | October 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor Btk Waldenström Macroglobulinemia |
WM Waldenström Macroglobulinemia |
Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |