Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies
Completed · Phase 1/Phase 2
Conditions studied: Non-Hodgkins Lymphoma, Multiple Myeloma, B-All
In brief
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.
Key facts
- Study ID
- NCT02328014
- Run by
- Acerta Pharma BV
- People needed
- 40
- Starts
- 2014-12-20
- Expected to finish
- 2025-10-30
- Last updated by the study team
- 2025-12-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
- Central nervous system (CNS) involvement by lymphoma/leukemia
- 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).
- 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.
Where it is running
- Research Site — Orange, California, United States
- Research Site — Bethesda, Maryland, United States
- Research Site — Rochester, New York, United States
- Research Site — Portland, Oregon, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Austin, Texas, United States
- Research Site — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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