Phase 2
Completed N=40
Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies
Non-Hodgkin's Lymphoma · Multiple Myeloma · B-All
Source: ClinicalTrials.gov NCT02328014 ↗
Enrolled (actual)
40
Serious AEs
55.0%
Results posted
Sep 2021
Primary outcomePrimary: Best Response and Overall Response Rate — 33.3; 0; 16.7; 18.2 percentage of participants
Summary
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Response and Overall Response Rate |
33.3; 0; 16.7; 18.2; 16.7; 0 | — |
Eligibility Criteria
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.
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 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 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.
Data sourced from ClinicalTrials.gov (NCT02328014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.