Trial record 1 of 1 for:
D8227C00001
A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) (ESCALADE)
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| ClinicalTrials.gov Identifier: NCT04529772 |
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Recruitment Status :
Recruiting
First Posted : August 28, 2020
Last Update Posted : November 14, 2023
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Sponsor:
Acerta Pharma BV
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Acerta Pharma BV
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Brief Summary:
Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diffuse Large B-Cell Lymphoma | Drug: acalabrutinib Drug: placebo Drug: Prednisone Drug: Rituximab Drug: Cyclophosphamide Drug: Vincristine Drug: Doxorubicin | Phase 3 |
Phase 3 randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as compared with placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma (activated B-cell (ABC) and unclassified).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Double-blind Randomised Placebo-controlled Study |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Participant Care provider Investigator Outcomes assessor |
| Primary Purpose: | Treatment |
| Official Title: | Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL |
| Actual Study Start Date : | October 8, 2020 |
| Estimated Primary Completion Date : | February 5, 2027 |
| Estimated Study Completion Date : | February 5, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Steroids
Drug Information
available for:
Acalabrutinib
| Arm | Intervention/treatment |
|---|---|
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Experimental: acalabrutinib + R-CHOP
Acalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
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Drug: acalabrutinib
Investigational Product Drug: Prednisone Investigational Product Drug: Rituximab Investigational Product Drug: Cyclophosphamide Investigational Product Drug: Vincristine Investigational Product Drug: Doxorubicin Investigational Product |
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Placebo Comparator: placebo + R-CHOP
Placebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
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Drug: placebo
Placebo comparator Drug: Prednisone Investigational Product Drug: Rituximab Investigational Product Drug: Cyclophosphamide Investigational Product Drug: Vincristine Investigational Product Drug: Doxorubicin Investigational Product |
Primary Outcome Measures :
- Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B [ Time Frame: at every single visit up to 60 months ]
Secondary Outcome Measures :
- Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B [ Time Frame: at every single visit up to 60 months ]
- Overall survival in Arm A compared to Arm B [ Time Frame: at every single visit up to 60 months ]
- Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification for NHL [ Time Frame: at every single visit up to 60 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women, age ≥18 and ≤75 years
- Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review.
- No prior treatment for DLBCL
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- International Prognostic Index (IPI) score of 1 to 5
- Disease Stage II to IV by the Ann Arbor Classification
- Adequate organ and marrow function
- Agreement to use highly effective forms of contraception during the study and 12 months after the last dose of rituximab
Exclusion Criteria:
- Evidence of severe or uncontrolled systemic diseases
- Known history of a bleeding diathesis (i.e., haemophilia, von Willebrand disease)
- History of stroke or intracranial haemorrhage in preceding 6 months.
- Known CNS lymphoma or leptomeningeal disease
- Known primary mediastinal lymphoma
- Known High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
- Prior history of indolent lymphoma or CLL
- History of or ongoing confirmed PML
- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
- Uncontrolled active systemic fungal, bacterial, viral, or other infection
- Prior anthracycline use ≥150 mg/m2
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): NCT04529772
Contacts
| Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Locations
Show 304 study locations
Sponsors and Collaborators
Acerta Pharma BV
AstraZeneca
| Responsible Party: | Acerta Pharma BV |
| ClinicalTrials.gov Identifier: | NCT04529772 |
| Other Study ID Numbers: |
D8227C00001 2019-001755-39 ( EudraCT Number ) |
| First Posted: | August 28, 2020 Key Record Dates |
| Last Update Posted: | November 14, 2023 |
| Last Verified: | November 2023 |
| 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: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Acerta Pharma BV:
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Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Lymphoma, Non-Hodgkin |
Prednisone Cyclophosphamide Rituximab Doxorubicin Vincristine Acalabrutinib Calquence |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Prednisone Cyclophosphamide Rituximab Doxorubicin Vincristine |
Acalabrutinib Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |