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BTK Inhibitor
Acalabrutinib for Diffuse Large B-Cell Lymphoma
Phase 1
Waitlist Available
Research Sponsored by Acerta Pharma BV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed or refractory disease
Pathologically confirmed de novo ABC DLBCL
Must not have
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
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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the date of disease progression, assessed up to cycle 48 (1 cycle is 28 days)
Awards & highlights
No Placebo-Only Group
Summary
This trial looked at the safety of a new drug, acalabrutinib, in people with a certain type of lymphoma that has come back or does not respond to treatment.
Who is the study for?
This trial is for adults over 18 with a specific type of lymphoma called de novo ABC DLBCL that has come back or hasn't responded to treatment. They must have at least one measurable site of the disease. It's not for those with serious heart issues, pregnant or breastfeeding women, anyone with life-threatening conditions, gastrointestinal disorders, or bowel obstruction.
What is being tested?
The trial is testing Acalabrutinib's safety in patients who have relapsed or are refractory to other treatments for the ABC subtype of Diffuse Large B-Cell Lymphoma (DLBCL).
What are the potential side effects?
While not explicitly listed here, common side effects from drugs like Acalabrutinib may include headaches, diarrhea, muscle and joint pain, reduced blood cell counts leading to increased infection risk and bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition has returned or didn't respond to treatment.
Select...
My cancer is a type of aggressive lymphoma diagnosed for the first time.
Select...
I have at least one tumor that can be measured.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition that affects how my stomach or intestines absorb food.
Select...
I do not have serious heart problems like recent heart attacks or severe heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to the date of disease progression, assessed up to cycle 48 (1 cycle is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the date of disease progression, assessed up to cycle 48 (1 cycle is 28 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
Secondary study objectives
Area Under the Plasma Concentration (AUC)
Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR)
Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)
+1 moreSide effects data
From 2020 Phase 2 trial • 177 Patients • NCT043461992%
Headache
1%
Septic shock
1%
Ischaemic stroke
1%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: AcalabrutinibExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2080
Find a Location
Who is running the clinical trial?
Acerta Pharma BVLead Sponsor
45 Previous Clinical Trials
5,904 Total Patients Enrolled
10 Trials studying Lymphoma
1,807 Patients Enrolled for Lymphoma
AstraZeneca Clinical TrialsStudy Director1-877-240-9479; information.center@astrazeneca.com
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any severe illnesses that could affect my safety or the study's results.I have a condition that affects how my stomach or intestines absorb food.I am 18 years old or older.My condition has returned or didn't respond to treatment.I do not have serious heart problems like recent heart attacks or severe heart failure.My cancer is a type of aggressive lymphoma diagnosed for the first time.I have at least one tumor that can be measured.
Research Study Groups:
This trial has the following groups:- Group 1: Acalabrutinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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