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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
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

Study 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.Check my eligibility
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).See study design
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
Select...
My condition has returned or didn't respond to treatment.
Select...
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
Secondary outcome measures
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%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC

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
~2050

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor
45 Previous Clinical Trials
5,904 Total Patients Enrolled
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
Diffuse Large B-Cell Lymphoma Research Study Groups: Acalabrutinib
Diffuse Large B-Cell 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the inaugural trial of its type?

"Since 2014, Acalabrutinib has been thoroughly studied. Its first clinical trial (sponsored by Acerta Pharma BV) took place in the same year and involved 306 patients. The drug received its Phase 1 & 2 approval afterwards and is currently being evaluated at 75 active studies around 507 cities across 47 nations."

Answered by AI

Have any prior experiments been conducted with Acalabrutinib?

"At present, there are 75 active studies concerning Acalabrutinib with 11 trials in their final phase. Most of the clinical investigations related to this drug take place within Houston, TX; however, it is also being studied across 2427 other sites."

Answered by AI

What is the safety profile of Acalabrutinib for those in treatment?

"Acalabrutinib's safety was assigned a value of 1 due to the early phase nature of this trial, which indicates limited evidence for both efficacy and security."

Answered by AI

Is this clinical trial recruiting participants of all ages, or is there an upper age limit?

"The parameters of the inclusion criteria dictate that prospective participants must be at least 18 years old and not older than 130."

Answered by AI

Is this research project currently enrolling participants?

"At present, this research is not recruiting any further participants. The trial was published on August 7th 2014 and the latest update occurred on September 1st 2022. On the other hand, 1766 studies are actively seeking patients with lymphoma while 75 trials offer Acalabrutinib treatment to enrolled individuals."

Answered by AI

What is the cap on enrollees for this medical experiment?

"Though the trial was initially posted in 2014 and updated as recently as September 1st 2022, it is not currently seeking patients. There are however 1766 trials recruiting for lymphoma research and 75 clinical studies that employ Acalabrutinib actively looking to enrol volunteers."

Answered by AI

How many venues are executing this experiment?

"This clinical trial is presently recruiting from 5 distinct medical centres, including Los Angeles, Columbus and Atlanta. It may be beneficial to choose the closest site for enrolment in order to reduce travel needs."

Answered by AI

Is it possible to register for participation in this experiment?

"For this trial, 21 volunteers that are between 18 and 130 years old with lymphoma must be enlisted. Furthermore, they need to meet the following criteria: Gender requirements (male or female), Pathological verification of their DLBCL diagnosis, Evidence of relapse/resistance to earlier treatment regimens and At least one measurable site for disease evaluation."

Answered by AI

What medical conditions have been treated most successfully with Acalabrutinib?

"Acalabrutinib is an effective therapy for treating mantle cell lymphoma (MCL), small lymphocytic lymphoma, and chronic lymphocytic leukemia (CLL)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
2014. "Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02112526.
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~2 spots leftby Apr 2025
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