Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)Phase 1NCT02112526
Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
A Phase 1 study testing Acalabrutinib in people with Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL), run by Acerta Pharma BV at 7 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)
- What is being tested?
- Acalabrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 7 Aug 2014to 4 Oct 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age.
- Pathologically confirmed de novo ABC DLBCL
- Relapsed or refractory disease
- Subjects must have ≥ 1 measurable disease sites
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Columbus, Ohio, 43210
Research Site
Houston, Texas, 77030
Research Site
Los Angeles, California, 90095
Research Site
New York, New York, 10021
United Kingdom2 sites
Research Site
Leicester, LE1 7RH
Research Site
Plymouth, PL6 8DH
About this study
Official title: 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
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).
- Being tested
- Acalabrutinib
- Keywords
- de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, de Novo Activated B-cell (ABC), de Novo Activated B-cell, ABC DLBCL, DLBCL, Lymphoma, B-Cell, Immunoproliferative Disorders, Immune System Diseases, Bruton's tyrosine kinase
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Immunoproliferative Disorders, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcalabrutinibDrug
Also called ACP-196
| Study group | Role | What they receive |
|---|---|---|
| Acalabrutinib | Experimental | Not described Receives: Drug: Acalabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.
Measured: SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.
Secondary outcomes (4)
Area Under the Plasma Concentration (AUC)
To Characterize the Pharmacokinetic parameter AUC of acalabrutinib
Measured: 1 Cycle (28 days)
Maximum Observed Plasma Concentration (Cmax)
To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib
Measured: 1 Cycle (28 days)
Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)
To evaluate the concentration pharmacodynamic effects of acalabrutinib
Measured: 2 Cycles (1 cycle = 28 days) and at end of treatment
Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR)
To evaluate the activity of acalabrutinib as measured by ORR
Measured: From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study start7 Aug 2014
- Primary completion30 Jun 2020
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)Studies of the same condition, open and under way.
- More trials run by Acerta Pharma BVThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca Clinical Trials, Study director, 1-877-240-9479; information.center@astrazeneca.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112526
- Sponsor's protocol ID
- ACE-LY-002
- Other IDs
- 2014-001341-25, 2014
- Status last verified
- Nov 2024
- First submitted
- 10 Apr 2014
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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: htttps://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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02112526
- Acronym / sponsor ID
- ACE-LY-002
- Keywords
- de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, de Novo Activated B-cell (ABC), de Novo Activated B-cell, ABC DLBCL, DLBCL, Lymphoma, B-Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Acerta Pharma BVIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2014 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Posted 29 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acalabrutinib | Experimental | Drug: Acalabrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women ≥ 18 years of age.
- Pathologically confirmed de novo ABC DLBCL
- Relapsed or refractory disease
- Subjects must have ≥ 1 measurable disease sites
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcalabrutinibAlso: ACP-196 | Drug | Acalabrutinib |
Primary outcome
Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
Time frame: SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.
Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.
4 secondary outcomes
Area Under the Plasma Concentration (AUC)
Time frame: 1 Cycle (28 days)
Maximum Observed Plasma Concentration (Cmax)
Time frame: 1 Cycle (28 days)
Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)
Time frame: 2 Cycles (1 cycle = 28 days) and at end of treatment
Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR)
Time frame: From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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: htttps://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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Clinical Trials study director
1-877-240-9479; information.center@astrazeneca.com
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acalabrutinib in people with Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL), run by Acerta Pharma BV at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL. (time frame: SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.