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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib vs Ibrutinib for Chronic Lymphocytic Leukemia

Phase 3

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 ≥ 1 of the following high-risk prognostic factors: Presence of 17p del by central laboratory, Presence of 11q del by central laboratory, Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment, Must have received ≥ 1 prior therapies for CLL

ECOG performance status of 0 to 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (days -28 to -1) through 83.7 months (maximum observed duration)

Awards & highlights

Study Summary

This trial is testing a new cancer drug against an existing one to see how well each extends the lives of patients with a specific kind of leukemia.

Who is the study for?

This trial is for adults over 18 with chronic lymphocytic leukemia (CLL) who have high-risk factors like certain genetic deletions or active disease requiring treatment. They must have had at least one prior CLL therapy, meet specific blood cell count criteria, and not be dependent on blood transfusions. People with a history of CNS leukemia, recent major surgery, or exposure to similar drugs are excluded.Check my eligibility

What is being tested?

The study compares the effectiveness of two drugs in treating CLL: Acalabrutinib and Ibrutinib. It focuses on which drug better prevents the disease from getting worse in patients who've already been treated before.See study design

What are the potential side effects?

Potential side effects for both Acalabrutinib and Ibrutinib include diarrhea, bleeding problems, high blood pressure, irregular heartbeat, muscle and bone pain, fatigue, rash as well as increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have high-risk CLL with specific genetic changes or need treatment based on certain criteria.

Select...

I can care for myself and am up and about more than 50% of my waking hours.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (days -28 to -1) through 83.7 months (maximum observed duration)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (days -28 to -1) through 83.7 months (maximum observed duration)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (days -28 to -1) through 83.7 months (maximum observed duration) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment

Secondary outcome measures

Number of Participants With Abnormal Vital Signs Reported as TEAEs

Number of Participants With Electrocardiogram (ECG) Abnormality at Baseline

Number of Participants With Shift From Baseline to Worst (Grade 3 and 4) Postbaseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

+7 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

2Treatment groups

Experimental Treatment

Active Control

Group I: AcalabrutinibExperimental Treatment1 Intervention

Participants will receive oral acalabrutinib 100 mg twice daily (BID) until disease progression (PD), or unacceptable toxicity, or other reasons for discontinuation, whichever occurs first.

Group II: IbrutinibActive Control1 Intervention

Participants will receive oral ibrutinib 420 mg once daily (QD) until PD, or unacceptable toxicity, or other reasons for discontinuation, whichever occurrs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2050

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor

45 Previous Clinical Trials

5,392 Total Patients Enrolled

Acerta Clinical TrialsStudy Director1-888-292-9613

17 Previous Clinical Trials

1,893 Total Patients Enrolled

Media Library

ACP-196 (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02477696 — Phase 3

Chronic Lymphocytic Leukemia Research Study Groups: Acalabrutinib, Ibrutinib

Chronic Lymphocytic Leukemia Clinical Trial 2023: ACP-196 Highlights & Side Effects. Trial Name: NCT02477696 — Phase 3

ACP-196 (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02477696 — Phase 3

Chronic Lymphocytic Leukemia Patient Testimony for trial: Trial Name: NCT02477696 — Phase 3

Frequently Asked Questions

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

Are there any documented dangers of ACP-196 for patients?

"ACP-196 has undergone Phase 3 clinical trials, meaning that there is some evidence of its efficacy and multiple rounds of data supporting its safety. Our team at Power rates its safety as a 3 on a scale of 1 to 3."

Answered by AI

Could you please share how many hospitals are administering this trial currently?

"To make participating more convenient for potential patients, this study is presently recruiting at 31 sites. These locations are primarily in the states of Washington and Virginia, but there are also 31 other sites."

Answered by AI

Can you tell me about other research projects that have used ACP-196?

"ACP-196 first underwent clinical trials in 2011 at the National Institutes of Health Clinical Center. In total, there have been 120 completed studies on the medication. Currently, there are 232 active trials, with a high concentration of these trials taking place in Tacoma, Washington."

Answered by AI

What are the most popular diseases that ACP-196 is used to target?

"The common course of treatment for mantle cell lymphoma is ACP-196. However, ACP-196 has also shown efficacy in treating waldenstrom macroglobulinemia, small lymphocytic lymphoma, and chronic lymphocytic leukemia."

Answered by AI

Are there any open vacancies in this study for willing participants?

"Unfortunately, this particular trial is no longer recruiting patients. Although, there are other ongoing studies that may be of interest. There are 1569 trials related to leukemia and 232 trials related to ACP-196 that are currently looking for participants."

Answered by AI