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
1 other identifier
interventional
40
1 country
7
Brief Summary
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2014
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2014
CompletedStudy Start
First participant enrolled
December 20, 2014
CompletedFirst Posted
Study publicly available on registry
December 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedResults Posted
Study results publicly available
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedDecember 9, 2025
November 1, 2025
5.5 years
December 18, 2014
May 21, 2021
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Response and Overall Response Rate
Best response and overall response rate per the criteria investigator uses for each disease histology. Standardized response and progression criteria is based on established criteria for B-cell malignancies, including WM (Cheson 2014; Owen 2013; Hallek 2008; Bladé 1998; and Durie 2006).
from the start of the treatment to the last evaluable disease assessment, an average of 1 year
Study Arms (1)
Dose Escalation and Expansion
EXPERIMENTALThe acalabrutinib dose will be fixed and the ACP-319 dose will be escalated in each of three cohorts, and each cohort will take both study drugs by mouth, twice per day (BID) at approximately 12 hour intervals. Expansion groups of up to 12 subjects for Germinal center B-cell (GCB) DLBCL and Non-GCB DLBCL to take a fixed dose of acalabrutinib and ACP-319. Each disease group will take both study drugs by mouth, twice per day (BID) at approximately 12 hour intervals.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acerta Pharma BVlead
- AstraZenecacollaborator
Study Sites (7)
Research Site
Orange, California, 92868, United States
Research Site
Bethesda, Maryland, 20892, United States
Research Site
Rochester, New York, 14642, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Austin, Texas, 78705, United States
Research Site
Seattle, Washington, 98109, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- Acerta Pharma
Study Officials
- STUDY DIRECTOR
AstraZeneca Clinical Study Infromation Center
1-877-240-9479 - information.center@astrazeneca.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2014
First Posted
December 31, 2014
Study Start
December 20, 2014
Primary Completion
June 1, 2020
Study Completion
October 30, 2025
Last Updated
December 9, 2025
Results First Posted
September 30, 2021
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.