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Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075292
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE August 19, 2019
First Posted Date  ICMJE August 30, 2019
Last Update Posted Date September 27, 2022
Actual Study Start Date  ICMJE January 20, 2020
Estimated Primary Completion Date October 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2019)		 Progression free survival (PFS) [ Time Frame: approximately 50 months ]
Progression free survival is defined as time from randomization until progression or death due to any cause (whichever occurs first)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • Objective response rate [ Time Frame: approximately 50 months ]
  • Duration of response [ Time Frame: approximately 50 months ]
  • Time to next treatment [ Time Frame: approximately 50 months ]
  • Overall survival [ Time Frame: approximately 50 months ]
  • Minimal residual disease negativity rate [ Time Frame: approximately 50 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 29, 2019)		 Incidence of adverse events [ Time Frame: approximately 50 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
Official Title  ICMJE 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
Brief Summary This is 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.
Detailed Description Patients be randomized in a 1:1 ratio into 2 arms to receive either acalabrutinib monotherapy (Arm A) or rituximab in combination with chlorambucil (Arm B). The primary objective of this study is to compare the efficacy of acalabrutinib relative to chlorambucil plus rituximab in subjects with previously untreated chronic lymphocytic leukemia without del(17p) or TP53 mutation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Untreated Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: Acalabrutinib
    acalabrutinib 100 mg twice daily orally
  • Drug: Rituximab
    Rituximab: 375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)
  • Drug: Chlorambucil
    Chlorambucil: 0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6
Study Arms  ICMJE
  • Experimental: Acalabrutinib
    Acalabrutinib will be orally administered until disease progression or unacceptable toxicity
    Intervention: Drug: Acalabrutinib
  • Active Comparator: Rituximab and Chlorambucil
    Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles
    Interventions:
    • Drug: Rituximab
    • Drug: Chlorambucil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2019)		 150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2024
Estimated Primary Completion Date October 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE China,   Philippines,   Taiwan,   Thailand,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04075292
Other Study ID Numbers  ICMJE D822BC00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lugui Qiu, MD Chinese Academy of Medical Science Affiliated Hospital of Hematology
PRS Account AstraZeneca
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP