Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤70 Years With Previously Untreated Non-GCB DLBCL (ESCALADE)

  • STATUS
    Recruiting
  • End date
    Aug 31, 2026
  • participants needed
    600
  • sponsor
    Acerta Pharma BV
Updated on 18 October 2022

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 ≤70 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.

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 ≤70 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma (activated B-cell (ABC) and unclassified).

Details
Condition Diffuse Large B-Cell Lymphoma
Treatment Rituximab, cyclophosphamide, prednisone, Placebo, vincristine, doxorubicin, acalabrutinib
Clinical Study IdentifierNCT04529772
SponsorAcerta Pharma BV
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women, age ≥18 and ≤70 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
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