This trial is active, not recruiting.

Condition waldenström macroglobulinemia (wm)
Treatment acalabrutinib
Phase phase 2
Target BTK
Sponsor Acerta Pharma BV
Start date July 2014
End date September 2017
Trial size 106 participants
Trial identifier NCT02180724, ACE-WM-001


This study is evaluating the safety and efficacy of acalabrutinib for the treatment of subjects with Waldenström Macroglobulinemia (WM)

United States Texas
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Acalabrutinib Regimen 1

Primary Outcomes

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

Eligibility Criteria

All participants at least 18 years old.

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.

Additional Information

Official title An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Acerta Pharma BV.