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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + ACP-319 for B-cell Cancers

Q: In what medical scenarios is Acalabrutinib typically prescribed?

<p>Acalabrutinib has been used to combat <a href="https://www.withpower.com/clinical-trials/mantle-cell-lymphoma">Mantle cell lymphoma</a>, Small Lymphocytic Leukemia and <a href="https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia">Chronic lymphocytic leukemia</a>.</p>

Phase 1 & 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

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

Diagnosis of a b-cell malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of the treatment to the last evaluable disease assessment, an average of 1 year

Awards & highlights

Study Summary

This trial is testing a new drug for safety, how it is processed by the body, and how well it works against B-cell cancers.

Who is the study for?

This trial is for people with B-cell malignancies like multiple myeloma or non-Hodgkin's lymphoma. Participants should be relatively active (ECOG ≤ 2), willing to use contraception, and have no major illnesses that could risk their safety or the study results. They shouldn't have had recent chemotherapy, extremely low blood cell counts not due to bone marrow disease, severe kidney or liver issues, CNS involvement by cancer, or any therapeutic antibodies in the last month.Check my eligibility

What is being tested?

The trial tests Acalabrutinib combined with ACP-319 on patients with B-cell cancers. It aims to assess how safe these drugs are together, how they affect the body (pharmacodynamics), how the body processes them (pharmacokinetics), and their effectiveness against these cancers.See study design

What are the potential side effects?

Potential side effects of Acalabrutinib and ACP-319 may include digestive problems, headaches, high blood pressure, minor bleeding issues like bruising easily due to lower platelets count in your blood and some infections because of a weakened immune system.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can take care of myself and am up and about more than half of the day.

Select...

My diagnosis is a B-cell cancer, confirmed by medical records and WHO criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of the treatment to the last evaluable disease assessment, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of the treatment to the last evaluable disease assessment, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the treatment to the last evaluable disease assessment, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Best Response and Overall Response Rate

Secondary outcome measures

Plasma

Evaluate Efficacy Activity of acalabrutinib and ACP-319 as measured by duration of response

Evaluate Efficacy Activity of acalabrutinib and ACP-319 as measured by progression-free survival

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and ExpansionExperimental Treatment2 Interventions

The acalabrutinib dose will be fixed and the ACP-319 dose will be escalated in each of three cohorts, and each cohort will take both study drugs by mouth, twice per day (BID) at approximately 12 hour intervals. Expansion groups of up to 12 subjects for Germinal center B-cell (GCB) DLBCL and Non-GCB DLBCL to take a fixed dose of acalabrutinib and ACP-319. Each disease group will take both study drugs by mouth, twice per day (BID) at approximately 12 hour intervals.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2050

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor

45 Previous Clinical Trials

5,885 Total Patients Enrolled

2 Trials studying Multiple Myeloma

188 Patients Enrolled for Multiple Myeloma

AstraZenecaIndustry Sponsor

4,259 Previous Clinical Trials

288,593,862 Total Patients Enrolled

7 Trials studying Multiple Myeloma

5,169 Patients Enrolled for Multiple Myeloma

AstraZeneca Clinical Study Infromation CenterStudy Director1-877-240-9479 - information.center@astrazeneca.com

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02328014 — Phase 1 & 2

Multiple Myeloma Research Study Groups: Dose Escalation and Expansion

Multiple Myeloma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT02328014 — Phase 1 & 2

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02328014 — Phase 1 & 2

Frequently Asked Questions

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

In what medical scenarios is Acalabrutinib typically prescribed?

"Acalabrutinib has been used to combat Mantle cell lymphoma, Small Lymphocytic Leukemia and Chronic lymphocytic leukemia."

Answered by AI

Are there records of other experiments involving Acalabrutinib in the past?

"There are currently 75 concurrent trials researching Acalabrutinib; 11 of them being in the late-stage Phase 3. While Houston, Texas has a major presence with clinical studies regarding this drug, it can be found at 2427 different sites worldwide."

Answered by AI

Are there many medical centers conducting this clinical trial across the United States?

"This experiment is taking place at 9 distinct locations, located in Portland, Nashville and Austin as well as other cities. When enrolling in this trial it's important to consider the nearest site for your convenience and to reduce travel costs."

Answered by AI

Are researchers seeking participants for this trial?

"Information on clinicaltrials.gov reveals that the study, which was first shared on December 20th 2014 and last updated October 19th 2022, is not presently recruiting patients. However, there are 3385 other medical trials actively enrolling participants at this time."

Answered by AI

What aims are being sought through this experiment?

"This clinical trial, which spans from the first dose of medication to 30 days after the last dosage, aims to measure Best Response and Overall Response Rate. Secondary objectives include assessing efficacy activity as measured by duration of response (interval between initial response rate documentation and definitive disease progression or death), evaluating pharmacodynamic effects (concentration-based responses) and calculating treatment's resulting response rate (proportion of patients achieving partial or complete documented results)."

Answered by AI

What is the aggregate number of participants in this trial?

"This trial is no longer open to new participants, having been posted on December 20th 2014 and ending October 19th 2022. However, those interested in trials related to multiple myeloma may find 3,310 studies currently enrolling patients while 75 more are recruiting for acalabrutinib treatments."

Answered by AI

Is this endeavor the inaugural research of its kind?

"Currently, Acalabrutinib is the subject of 75 studies being conducted in 507 cities and 47 countries. This drug's initial trial began in 2014 when 306 patients participated in a Phase 1 & 2 examination sponsored by Acerta Pharma BV. Since then, 24 additional trials have been concluded."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies

2014. "Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02328014.

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