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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + ACP-319 for Chronic Lymphocytic Leukemia

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

Men and women ≥ 18 years of age with a confirmed diagnosis of CLL, which has relapsed after, or been refractory to, ≥ 1 previous treatments for CLL; however, subjects with 17p deletion are eligible if they have relapsed after, or been refractory to, 1 prior treatment for CLL.

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. after that at cycle 48 and 60 of 28 day cycles.

Awards & highlights

Study Summary

This trial is testing a new combination treatment for CLL. Early results show it is effective and has few side effects.

Who is the study for?

Adults over 18 with chronic lymphocytic leukemia (CLL) that has come back or didn't respond to at least one treatment can join this trial. Those with certain genetic changes in their CLL may qualify after just one prior treatment. Participants must be able to perform daily activities with relative ease, agree to use birth control, and not have other serious health issues or recent treatments that could affect the study.Check my eligibility

What is being tested?

The trial is testing a combination of two drugs, acalabrutinib and ACP-319, for treating CLL. It aims to find out how safe this combo is and how well it works against the disease.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones for cancer treatments like these might include nausea, fatigue, headache, diarrhea, and potential risks related to blood counts and organ function.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am over 18 and my CLL has not improved after at least one treatment, or it came back.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. after that at cycle 48 and 60 of 28 day cycles.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. after that at cycle 48 and 60 of 28 day cycles.

This trial's timeline: 3 weeks for screening, Varies for treatment, and pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. after that at cycle 48 and 60 of 28 day cycles. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

Drug Exposure, Area Under the Plasma Concentration-time Curve

Drug Exposure, Maximum observed plasma concentration

Drug Exposure, Time of the maximum plasma concentration

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: acalabrutinibExperimental Treatment2 Interventions

Starts with acalabrutinib for 7 days, then combined with ACP-319 afterwards.

Group II: ACP-319Experimental Treatment2 Interventions

Starts with ACP-319 for 7 days, then combined with acalabrutinib afterwards.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

acalabrutinib

2018

Completed Phase 2

~80

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor

45 Previous Clinical Trials

5,913 Total Patients Enrolled

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

17 Previous Clinical Trials

2,414 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02157324 — Phase 1

Chronic Lymphocytic Leukemia Research Study Groups: ACP-319, acalabrutinib

Chronic Lymphocytic Leukemia Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT02157324 — Phase 1

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02157324 — Phase 1

Frequently Asked Questions

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

What maladies has ACP-319 been instrumental in ameliorating?

"ACP-319 is a potent therapeutic agent used to address conditions such as Mantle cell lymphoma (MCL), Small Lymphocytic Leukemia and Chronic lymphocytic leukemia (CLL)."

Answered by AI

Are there any prior experiments involving ACP-319 that have been documented?

"At present, 75 medical studies are underway to investigate the efficacy of ACP-319. Of those active trials, 11 have reached Phase 3 status. Although most research is conducted in Houston, Texas; globally there exist 2427 different clinical trial sites with relevant data for this particular intervention."

Answered by AI

What is the aggregate figure for participants enrolled in this research project?

"This medical study has already concluded its recruitment period. It was made available on August 18th 2014 and last updated on the 25th of August 2022. However, there are currently 1522 trials actively enrolling people with leukemia and 75 studies involving ACP-319 that need participants.."

Answered by AI

Has this particular clinical trial been conducted before?

"Acerta Pharma BV began research on ACP-319 in 2014 with a Phase 1 & 2 study of 306 participants. Subsequently, this biologic received approval and is now the subject of 75 active trials spanning 507 cities and 47 nations."

Answered by AI

Are researchers currently enrolling participants for this experiment?

"This clinical trial has ceased recruitment, having first been posted on August 18th 2014 and last updated on August 25th 2022. Fortunately, there are plenty of other options for leukemia patients with 1522 trials that are currently admitting participants as well as 75 studies recruiting volunteers to receive ACP-319."

Answered by AI

Are there numerous establishments conducting this research in Canada?

"This trial is now enrolling patients from 4 distinct medical centres. These sites are located in Hermitage, Columbus and Fort Worth as well as other locales. It may be prudent to select the closest site to limit your travel needs should you choose to participate."

Answered by AI

What are the safety profiles associated with ACP-319?

"Owing to the limited data available regarding its safety and efficacy, ACP-319 received a score of 1 on our team's scale. This is due to it being an early phase one trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acalabrutinib in Combination With ACP-319, for Treatment of Chronic Lymphocytic Leukemia

2014. "Acalabrutinib in Combination With ACP-319, for Treatment of Chronic Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02157324.

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