Acalabrutinib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Acerta Pharma BV

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Eligibility Criteria

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.

Inclusion Criteria

I am 18 or older with a confirmed diagnosis.

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)

Exclusion Criteria

My condition has transformed into a more aggressive form of cancer.

I haven't had cancer treatments or experimental drugs in the last 4 weeks.

I need steroids for my autoimmune blood condition.

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Treatment Details

Interventions

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.

Acalabrutinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Calquence for: