Clinical trial · Interventional
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
NCT02112526CI-TRIAL-00084004completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL) | Diffuse Large B-Cell Lymphoma Activated B-Cell Type | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acalabrutinib | Drug | Acalabrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Acalabrutinib
- interventionNames
- Drug: Acalabrutinib
Primary outcomes (1)
- measure
- Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
- timeFrame
- SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.
- description
- Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.
Secondary outcomes (4)
- measure
- Area Under the Plasma Concentration (AUC)
- timeFrame
- 1 Cycle (28 days)
- description
- To Characterize the Pharmacokinetic parameter AUC of acalabrutinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women ≥ 18 years of age. * Pathologically confirmed de novo ABC DLBCL * Relapsed or refractory disease * Subjects must have ≥ 1 measurable disease sites 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 \< 50% * 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. * Breast feeding or pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.