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

NCT04075292

Description:

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.

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: D822BC00001
  • NCT ID: NCT04075292

Conditions

  • Untreated Chronic Lymphocytic Leukemia

Interventions

DrugSynonymsArms
AcalabrutinibAcalabrutinib
RituximabRituximab and Chlorambucil
ChlorambucilRituximab and Chlorambucil

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
AcalabrutinibExperimentalAcalabrutinib will be orally administered until disease progression or unacceptable toxicity
  • Acalabrutinib
Rituximab and ChlorambucilActive ComparatorChlorambucil orally administered and Rituximab via IV infusion for 6 cycles
  • Rituximab
  • Chlorambucil

Eligibility 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:

          -  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
      
Maximum Eligible Age:130 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:approximately 50 months
Safety Issue:
Description:Progression free survival is defined as time from randomization until progression or death due to any cause (whichever occurs first)

Secondary Outcome Measures

Measure:Objective response rate
Time Frame:approximately 50 months
Safety Issue:
Description:
Measure:Duration of response
Time Frame:approximately 50 months
Safety Issue:
Description:
Measure:Time to next treatment
Time Frame:approximately 50 months
Safety Issue:
Description:
Measure:Overall survival
Time Frame:approximately 50 months
Safety Issue:
Description:
Measure:Minimal residual disease negativity rate
Time Frame:approximately 50 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • Chronic Lymphocytic Leukemia
  • Acalabrutinib
  • Progression-free Survival

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