Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
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| ClinicalTrials.gov Identifier: NCT04075292 |
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Recruitment Status :
Recruiting
First Posted : August 30, 2019
Last Update Posted : January 18, 2022
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Untreated Chronic Lymphocytic Leukemia | Drug: Acalabrutinib Drug: Rituximab Drug: Chlorambucil | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 20, 2020 |
| Estimated Primary Completion Date : | October 31, 2024 |
| Estimated Study Completion Date : | October 31, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Acalabrutinib
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity
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Drug: Acalabrutinib
acalabrutinib 100 mg twice daily orally |
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Active Comparator: Rituximab and Chlorambucil
Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles
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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 |
Primary Outcome Measures :
- 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)
Secondary Outcome Measures :
- 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 ]
Other Outcome Measures:
- Incidence of adverse events [ Time Frame: approximately 50 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075292
Contacts
| Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Locations
Show 55 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Lugui Qiu, MD | Chinese Academy of Medical Science Affiliated Hospital of Hematology |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT04075292 |
| Other Study ID Numbers: |
D822BC00001 |
| First Posted: | August 30, 2019 Key Record Dates |
| Last Update Posted: | January 18, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by AstraZeneca:
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Chronic Lymphocytic Leukemia Acalabrutinib Progression-free Survival |
Additional relevant MeSH terms:
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Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Rituximab |
Acalabrutinib Chlorambucil Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |