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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 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
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: ACP-196 (acalabrutinib)Experimental Treatment1 Intervention
ACP-196 (acalabrutinib) 100 mg to be administered orally (PO) twice a day BID

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
~7 spots leftby Jun 2025
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