NCT02328014CompletedPhase 1/2
Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies
A Phase 1/2 Proof-of-Concept Study of the Combination of ACP-196 and ACP-319 in Subjects With B-cell Malignancies
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 18 Dec 2014
- Start date
- 20 Dec 2014
- Primary completion date
- 1 Jun 2020
- Lead sponsor
- Acerta Pharma BV
- NCT number
- NCT02328014
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 40
- From 20 Dec 2014 to the primary completion date, 1 Jun 2020
- 7 sites in 1 country
- 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.
Prior treatment
- Any therapeutic antibody within 4 weeks of first dose of study drugs.
- The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drugs is \< 5 times the half-life of the previously administered agent(s).
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 study drugs, or put the study outcomes at undue risk.
Lab values
- ANC \< 0.5 x 10\^9/L or platelet count \< 50 x 10\^9/L unless due to disease involvement in the bone marrow.
- Creatinine \> 1.5 x institutional upper limit of normal (ULN); total bilirubin \> 1.5 x ULN (unless due to Gilbert's disease); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3.0 x ULN.
Other
- Central nervous system (CNS) involvement by lymphoma/leukemia
Criteria the registry did not label
- Main Inclusion Criteria:
- Diagnosis of a b-cell malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO).
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Agreement to use contraception during the study and for 90 days after the last dose of study drugs if sexually active and able to bear or beget children.
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 | Austin | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.