Trial record 1 of 1 for: D8227C00001

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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

Recruitment Status : Active, not recruiting

First Posted : August 28, 2020

Last Update Posted : March 12, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

AstraZeneca

Information provided by (Responsible Party):

Acerta Pharma BV

Tracking Information

First Submitted Date ^ICMJE

August 25, 2020

First Posted Date ^ICMJE

August 28, 2020

Last Update Posted Date

March 12, 2024

Actual Study Start Date ^ICMJE

October 8, 2020

Estimated Primary Completion Date

February 5, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B [ Time Frame: 60 months ]

Change History

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B [ Time Frame: 60 months ]
Overall survival in Arm A compared to Arm B [ Time Frame: 60 months ]
Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification at the end of study treatment [ Time Frame: Up to 32 weeks ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)

Official Title ^ICMJE

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

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.

Detailed Description

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 ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Diffuse Large B-Cell Lymphoma

Intervention ^ICMJE

Drug: acalabrutinib
Investigational Product
Drug: placebo
Placebo comparator
Drug: Prednisone
Investigational Product
Drug: Rituximab
Investigational Product
Drug: Cyclophosphamide
Investigational Product
Drug: Vincristine
Investigational Product
Drug: Doxorubicin
Investigational Product

Study Arms ^ICMJE

Experimental: acalabrutinib + R-CHOP
Acalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
Interventions:
- Drug: acalabrutinib
- Drug: Prednisone
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Doxorubicin
Placebo Comparator: placebo + R-CHOP
Placebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
Interventions:
- Drug: placebo
- Drug: Prednisone
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Doxorubicin

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

Active, not recruiting

Actual Enrollment ^ICMJE

611

Original Estimated Enrollment ^ICMJE

600

Estimated Study Completion Date ^ICMJE

February 5, 2027

Estimated Primary Completion Date

February 5, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04529772

Other Study ID Numbers ^ICMJE

D8227C00001
2019-001755-39 ( EudraCT Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
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