← Back to Search

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
Active disease as defined by at least one of the following (IWCLL consensus criteria): Weight loss ≥10% within the previous 6 months, Extreme fatigue, Fevers of greater than 100.5ºF for ≥2 weeks without evidence of infection, Night sweats for more than one month without evidence of infection, Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia, Massive or progressive splenomegaly, Massive nodes or clusters or progressive lymphadenopathy, Progressive lymphocytosis with an increase of >50% over a 2 month period, or an anticipated doubling time of less than 6 months, Compensated autoimmune hemolysis, Relapsed/Refractory CLL or treatment naïve CLL patients with 17p deletion, TP53 mutation, or NOTCH1 mutation, Agreement to use acceptable methods of contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear or beget children, Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty and serial biopsies, Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Must not have
Richter's transformation
Autoimmune hemolytic anemia or thrombocytopenia requiring steroid therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 (28 days) to 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, acalabrutinib, for leukemia and lymphoma.

Who is the study for?
Adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, specifically those who have relapsed/refractory disease or are treatment-naive with certain genetic mutations (17p deletion, TP53, NOTCH1). Participants must experience significant symptoms like weight loss, fevers without infection, night sweats, fatigue, enlarged spleen/lymph nodes or rapid increase in white blood cells. They should be able to swallow capsules and undergo biopsies.
What is being tested?
The trial is testing Acalabrutinib's effectiveness for two groups of patients: those who have previously been treated for CLL/SLL and those who haven't. The goal is to see how well the drug works in controlling the disease across different patient backgrounds.
What are the potential side effects?
Acalabrutinib may cause headaches, diarrhea, muscle pain and bruising. Some people might also experience more serious effects like bleeding problems or infections due to low blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My condition has transformed into a more aggressive form of cancer.
Select...
I need steroids for my autoimmune blood condition.
Select...
My liver isn't working properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 (28 days) to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 (28 days) to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Heart rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment2 Interventions
Subjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily.
Group II: Arm AExperimental Treatment2 Interventions
Subjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,563 Total Patients Enrolled
Acerta Pharma BVLead Sponsor
45 Previous Clinical Trials
5,877 Total Patients Enrolled
AstraZeneca Clinical Study Information CenterStudy Director1-877-240-9479 - information.center@astrazeneca.com
2 Previous Clinical Trials
696 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02337829 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Arm A, Arm B
Chronic Lymphocytic Leukemia Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT02337829 — Phase 2
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02337829 — Phase 2
~4 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top