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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 below
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My condition has returned or didn't respond to treatment.
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My cancer is a type of aggressive lymphoma diagnosed for the first time.
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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:
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I have a condition that affects how my stomach or intestines absorb food.
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I do not have serious heart problems like recent heart attacks or severe heart failure.

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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the date of disease progression, assessed up to cycle 48 (1 cycle is 28 days) for reporting.

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 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
2%
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

Acalabrutinib (BTK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02112526 — Phase 1
Lymphoma Research Study Groups: Acalabrutinib
Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT02112526 — Phase 1
Acalabrutinib (BTK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02112526 — Phase 1
~2 spots leftby Nov 2025