drugset / Trial / NCT04523428

REtreatment With VEnetoclax and Acalabrutinib After Venetoclax Limited Duration (REVEAL)

NCT04523428

Phase 2 Recruiting 60 enrolled HOVON Foundation
NaSingle-groupOpen-labelTreatment

Summary

Fixed-duration regimens containing combinations of venetoclax with CD20 targeting agents are expected to soon become standard practice in first-line patients with chronic lymfocytic leukemia (CLL). The advantage of a fixed duration venetoclax combination as part of first-line treatment is the potential to retreat with venetoclax in patients who develop relapsed disease after a treatment free period. However, efficacy of venetoclax retreatment following a fixed duration venetoclax combination is still hypothetical as clinical data are lacking. Thus, there is an urgent need for data proving efficacy of venetoclax combinations following venetoclax treatment cessation. Testing of a novel venetoclax-containing regimen for relapsed CLL without the repeat of anti-CD20 monoclonal antibody (mAb) is a rational approach.

Timeline

Start
2020-12-23
Primary completion
2028-12
Completion
2032-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Acalabrutinib Small molecule 100 mg
Subject Venetoclax Small molecule 400 mg