NCT02112526CompletedPhase 1
Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
An Open-label, Phase 1b Study of ACP 196 in Subjects With Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
Source: ClinicalTrials.gov · Last updated 20 Dec 2024
Brief summary (registry, in English)
To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 10 Apr 2014
- Start date
- 7 Aug 2014
- Primary completion date
- 30 Jun 2020
- Lead sponsor
- Acerta Pharma BV
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT02112526
- EudraCT number
- 2014-001341-25
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 21
- From 7 Aug 2014 to the primary completion date, 30 Jun 2020
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
Lab values
- 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 \< 50%
Other
- Breast feeding or pregnant
Who the study is looking for
- Men and women ≥ 18 years of age.
- Pathologically confirmed de novo ABC DLBCL
- Relapsed or refractory disease
- Subjects must have ≥ 1 measurable disease sites
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.