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RecruitingLast updated: 22 December 2023

ESCALADE: This trial aims to assess the safety and effectiveness of combined anti-cancer treatment in patients with previously untreated diffuse large B-cell lymphomaPhase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Subjects ≤65 Years With Previously Untreated Non-Germinal Center DLBCL

Clinical summary

Summary

Eligible participants will be randomised into one of two groups and will receive either acalabrutinib or a placebo, in combination with Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) chemotherapy.

Conditions

This trial is treating patients with Diffuse Large B-Cell Lymphoma

Cancer

Blood Cancers Haematological

Age

People18 - 65

Phase

III

Trial Acronym

ESCALADE

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Acerta Pharma BV

Scientific Title

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Subjects ≤65 Years With Previously Untreated Non-Germinal Center DLBCL

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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