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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib for Chronic Lymphocytic Leukemia

Phase 2

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

Must have received ≥ 1 prior therapy for CLL

ECOG performance status of ≤ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)

Awards & highlights

Study Summary

This trial is testing a new drug for people with a specific type of leukemia who have stopped responding to treatment with another drug.

Who is the study for?

This trial is for adults with Chronic Lymphocytic Leukemia (CLL) who've had at least one prior treatment and can't tolerate Ibrutinib. They should have progressed after stopping Ibrutinib, be able to swallow capsules, and have a decent performance status. Exclusions include other cancers within 2 years, significant gut surgery or diseases affecting absorption, active infections including HIV/Hepatitis B/C, recent major surgery or heart issues, bleeding disorders, certain drug interactions, previous BCL-2 inhibitor use like Venetoclax.Check my eligibility

What is being tested?

The study tests Acalabrutinib's effectiveness and safety in patients with relapsed/refractory CLL intolerant to Ibrutinib therapy. It's a Phase 2 trial focusing on those who didn't respond well to their previous treatments.See study design

What are the potential side effects?

Acalabrutinib may cause side effects such as headaches, diarrhea, muscle pain and bruising easily due to low blood platelets. More serious but less common side effects could include bleeding problems or infections due to low white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had at least one treatment for chronic lymphocytic leukemia.

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I can take care of myself but might not be able to do heavy physical work.

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My condition worsened after stopping ibrutinib as per specific criteria.

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I have been diagnosed with chronic lymphocytic leukemia (CLL) before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib)

Secondary outcome measures

Duration of Response

Overall Survival

Progression-Free Survival

+1 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Chronic obstructive pulmonary disease

Septic shock

Ischaemic stroke

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

Trial Design

1Treatment groups

Experimental Treatment

Group I: ACP-196 (acalabrutinib)Experimental Treatment1 Intervention

ACP-196 (acalabrutinib) 100 mg to be administered orally (PO) twice a day BID

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor

45 Previous Clinical Trials

5,865 Total Patients Enrolled

Acerta Clinical TrialsStudy Director1-888-292-9613; acertamc@dlss.com

17 Previous Clinical Trials

2,366 Total Patients Enrolled

Media Library

ACP-196 (acalabrutinib) (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02717611 — Phase 2

Chronic Lymphocytic Leukemia Research Study Groups: ACP-196 (acalabrutinib)

Chronic Lymphocytic Leukemia Clinical Trial 2023: ACP-196 (acalabrutinib) Highlights & Side Effects. Trial Name: NCT02717611 — Phase 2

ACP-196 (acalabrutinib) (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02717611 — Phase 2

Frequently Asked Questions

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

How many participants have been accepted for this trial?

"At present, this trial is not open for enrollment. Initially posted on March 8th 2016 and most recently updated on September 6th 2022, there are other clinical trials available to explore. There are currently 666 studies seeking patients with various forms of leukemia while 75 require the use of ACP-196 (acalabrutinib)."

Answered by AI

What role does ACP-196 (acalabrutinib) play in treatment?

"ACP-196 (acalabrutinib) is a viable treatment option for individuals suffering from Mantle cell lymphoma, Small Lymphocytic Leukemia and Chronic lymphocytic leukemia."

Answered by AI

Could you elaborate on the history of research involving ACP-196 (acalabrutinib)?

"ACP-196 (acalabrutinib) was initially researched in 2014 at a specific research site. Currently, there have been 24 completed trials and 75 active studies are currently recruiting participants, mostly located in Concord, California."

Answered by AI

How many areas have access to this trial's offerings?

"This medical trial is currently accepting new participants from 15 distinct locations, such as Concord, La Jolla and Spokane. To reduce the strain of travel if you choose to join the study, it's best to select a clinic in close proximity."

Answered by AI

To what extent can ACP-196 (acalabrutinib) lead to adverse effects in patients?

"ACP-196 (acalabrutinib) is still in Phase 2 trials, meaning that there has been evidence to suggest its safety but none yet for efficacy. Therefore, our team at Power attributed a score of 2 on the 1-3 scale when evaluating this drug's safety profile."

Answered by AI

What is the intended result of this clinical investigation?

"The primary outcome of this trial, monitored from the first dose until death or documented progression (up to 4 years and 7 months), will be the overall response rate (ORR) of ACP-196. Secondary objectives include measuring overall survival, duration of response, and progression-free survival which are respectively defined as: the total lifespan; date achieving CR/PR - date disease progressed/died; date disease progressed/died minus first dose + 1 day."

Answered by AI

Has this experiment ever been attempted before?

"As of today, there are 75 active clinical trials for acalabrutinib in 507 cities and 47 nations. The first trial for the drug was run by Acerta Pharma BV back in 2014, with 306 participants taking part to reach a Phase 1 & 2 approval. Since then 24 other studies have been finalized."

Answered by AI

Are there any vacant slots in this trial for eligible participants?

"As reported on clinicaltrials.gov, this medical trial is no longer recruiting new patients; its inception was dated March 8th 2016 and the latest update occurred September 6th 2022. However, there are currently 741 other trials actively searching for research subjects."

Answered by AI

Recent research and studies

BloodJournal

Outcomes of CLL Patients Treated with Sequential Kinase Inhibitor Therapy: A Real World Experience

Mato, Anthony R., Chadi Nabhan, Paul M. Barr, Chaitra S. Ujjani, Brian T. Hill, Nicole Lamanna, Alan P. Skarbnik, et al.. 2016. “Outcomes of CLL Patients Treated with Sequential Kinase Inhibitor Therapy: A Real World Experience”. Blood. American Society of Hematology. doi:10.1182/blood-2016-05-716977.

HaematologicaJournal

Phase II Study of Acalabrutinib in Ibrutinib-intolerant Patients with Relapsed/refractory Chronic Lymphocytic Leukemia

Rogers, Kerry A., Philip A. Thompson, John N. Allan, Morton Coleman, Jeff P. Sharman, Bruce D. Cheson, Daniel Jones, et al.. 2021. “Phase II Study of Acalabrutinib in Ibrutinib-intolerant Patients with Relapsed/refractory Chronic Lymphocytic Leukemia”. Haematologica. Ferrata Storti Foundation (Haematologica). doi:10.3324/haematol.2020.272500.

clinicaltrials.govStudy

A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

2016. "A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02717611.