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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

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 (28 days) to 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 (28 days) to 6 months

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

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

Primary outcome measures

Heart rate

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,540 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

Frequently Asked Questions

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

Are there any analogous studies which have evaluated Acalabrutinib (Arm A)?

"Currently, 75 investigations into Acalabrutinib (Arm A) are being conducted. 11 of these studies have progressed to the third stage of clinical trials while a whopping 2427 sites are running research pertaining to this medication in Houston and beyond."

Answered by AI

Does this trial represent an innovative approach to the research?

"Acalabrutinib (Arm A) has been studied since 2014 when Acerta Pharma BV sponsored its first clinical trial, which included 306 participants. Subsequently, this drug received Phase 1 & 2 approval and is now being examined in 75 active studies across 47 countries and 507 cities."

Answered by AI

What are the long-term safety implications of taking Acalabrutinib (Arm A)?

"Our team at Power rated Acalabrutinib's safety as a 2 out of 3 due to the Phase 2 trial status, with some evidence supporting its security but no data validating its efficacy."

Answered by AI

What maladies is Acalabrutinib (Arm A) often utilized for?

"Acalabrutinib is a viable treatment option for Mantle cell lymphoma (MCL), Small Lymphocytic Lymphoma and Chronic Lyphocytic Leukemia (CLL) patients enrolled in Arm A."

Answered by AI

Is enrollment for this clinical trial still available?

"Unfortunately, the clinical trial hosted on clinicialtrials.gov is not accepting new patients at this time; the last update was posted October 7th 2022. However, there are 2937 other trials actively recruiting individuals across various cities and countries."

Answered by AI

What is the upper cap of participants in this experiment?

"Unfortunately, this study has already concluded its recruitment phase. First initiated on December 1st 2015 and last updated October 7th 2022, the trial is now closed for patient enrollment. For those seeking alternative studies, 2862 trials are presently open to patients with leukemia while 75 clinical trials enlisting participants into Arm A of Acalabrutinib treatment have yet to reach their quotas."

Answered by AI

Recent research and studies

BloodJournal

Clinical and Biological Implications of Target Occupancy in CLL Treated with the BTK Inhibitor Acalabrutinib

Sun, Clare, Pia Nierman, Ellen K. Kendall, Jean Cheung, Michael Gulrajani, Sarah E. M. Herman, Christopher Pleyer, et al.. 2020. “Clinical and Biological Implications of Target Occupancy in CLL Treated with the BTK Inhibitor Acalabrutinib”. Blood. American Society of Hematology. doi:10.1182/blood.2019003715.

Clinical Cancer ResearchJournal

Pharmacodynamic Analysis of BTK Inhibition in Patients with Chronic Lymphocytic Leukemia Treated with Acalabrutinib

Alsadhan, Anfal, Jean Cheung, Michael Gulrajani, Erika M. Gaglione, Pia Nierman, Ahmed Hamdy, Raquel Izumi, et al.. 2020. “Pharmacodynamic Analysis of BTK Inhibition in Patients with Chronic Lymphocytic Leukemia Treated with Acalabrutinib”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-19-3505.

clinicaltrials.govStudy

Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL

2015. "Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02337829.