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Clinical Trials List

Protocol NumberD822BC00001
NCT Number(ClinicalTrials.gov Identfier)NCT04075292
Active

2019-12-01 - 2025-12-31

Phase III

Recruiting4

Terminated5

ICD-10C91.90

Lymphoid leukemia, unspecified not having achieved remission

A Randomized, Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Acalabrutinib Versus Chlorambucil Plus Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/12/01

Investigators and Locations

Principal Investigator Po-Nan Wang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉鴻霖 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Liang-Tsai Hsiao Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Shang-Ju Wu Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 吳育穎 Division of Hematology & Oncology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 滕傑林 Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 吳懿峰 Division of Hematology & Oncology
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Untreated Chronic Lymphocytic Leukemia

Objectives

Primary objective:To compare the efficacy of acalabrutinib relativeto chlorambucil plus rituximab in subjects withpreviously untreated chronic lymphocyticleukemia without del(17p) or TP53 mutation Secondary objectives: To compare acalabrutinib relative tochlorambucil plus rituximab on objectiveresponse rate, duration of response, time to nexttreatment, and overall survivalTo evaluate minimal residual disease negativityrate during treatment and at the end of treatmentTo characterize the pharmacokinetics ofacalabrutinib and its major metabolite(ACP-5862)Safety objective: To assess the safety and tolerability ofacalabrutinib as compared to chlorambucil plusrituximab in subjects with previously untreatedchronic lymphocytic leukemia without del(17p)or TP53 mutation

Test Drug

Acalabrutinib (ACP-196)

Active Ingredient

Acalabrutinib

Dosage Form

capsule

Dosage

100

Endpoints

Primary:
Progression free survival is defined as time from
randomization until progression per the
International Workshop on Chronic
Lymphocytic Leukemia 2018 criteria as assessed
by blinded independent central review or death
due to any cause

Secondary:
 Overall response rate is defined as the
proportion of patients who have a complete
response, complete response with incomplete
bone marrow recovery, or partial response, as
determined by blinded independent central
review and investigator per International
Workshop on Chronic Lymphocytic
Leukemia 2018 criteria
 Duration of response is defined as the time
from the date of first documented response
until date of documented progression or
death in the absence of disease progression,
as determined by blinded independent central
review and investigator
 Time to next therapy is defined as time from
randomization until institution of nonprotocol specified treatment for chronic
lymphocytic leukemia
 Overall survival is the length of time from
randomization until the date of death due to
any cause

Minimal residual disease negativity rate
(peripheral blood) at the start of Cycle 9

Summarized plasma concentrations of
acalabrutinib and ACP-5862 at specified time
points
Pharmacokinetic parameters by population
analyses as appropriate

Safety:
Safety and tolerability will be evaluated in terms
of adverse events, vital signs, clinical laboratory,
physical examinations, and electrocardiogram
Assessments related to adverse events cover
 Occurrence/frequency
 Relationship to investigational product as
assessed by investigator
 Common Terminology Criteria for Adverse
Events severity grade
 Seriousness
 Death
 Adverse events leading to discontinuation of
investigational product
 Adverse events leading to dose reduction of
investigational product
 Adverse events leading to dose delay of
investigational product
Vital signs parameters include systolic and
diastolic blood pressure, and pulse rate, body
temperature.
Assessments cover
 Observed value
 Absolute change from baseline values over
time

Exploratory:

European Organization for Research and
Treatment of Cancer: Quality of Life
Questionnaire Core 30
Functional Assessment of Chronic Illness
Therapy: Fatigue

EQ-5D-5L Health State Utility Index

Inclution Criteria

Inclusion Criteria:

Men and women: (a) ≥65 years of age OR (b) >18 and <65 years of age, provided that they meet at least one of the following criteria: (i) Creatinine clearance 30 to 69 mL/min using the Cockcroft-Gault equation (iwCLL guidelines) (ii) A score higher than 6 on the Cumulative Illness Rating Score-Geriatric (CIRS G)
ECOG performance status of 0, 1, or 2
Diagnosis of CLL that meets published diagnostic criteria (Hallek 2018)
Active disease per IWCLL 2018 criteria that requires treatment
Adequate bone marrow function
Adequate renal and hepatic function

Exclusion Criteria

Exclusion Criteria:

Known detected del(17p) or TP53 mutation
Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (eg, Richter's transformation, PLL, or diffuse large B cell lymphoma [DLBCL]), or central nervous system (CNS) involvement by leukemia
History of prior malignancy except for the following: (a) Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study (b) Other cancers not specified above which have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for ≥3 years without further treatment
Significant cardiovascular disease
Known history of infection with human immunodeficiency virus (HIV)
Serologic status reflecting active hepatitis B or C infection
Any active systemic infection (eg, bacterial, viral, or fungal infection) requiring systemic treatment
History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
Major surgical procedure within 30 days of first dose of study drug
Any prior CLL-specific therapies
Corticosteroid use >20 mg within 1 week before first dose of study drug, except as indicated for other medical conditions
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
For women only: breastfeeding or pregnant

The Estimated Number of Participants

  • Taiwan

    21 participants

  • Global

    150 participants

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