A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL

This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation, complex karyotype or an unmutated IGHV-gene status).

Trial Details

NCT ID
NCT05197192
Phase
PHASE3
Sponsor
German CLL Study Group
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Obinutuzumab
  • Venetoclax
  • Acalabrutinib
Locations (sample)
  • Bad Saarow, Germany|52.28333,14.06667
  • Berlin, Germany|52.52437,13.41053
  • Bremen, Germany|53.07582,8.80717
  • Cologne, Germany|50.93333,6.95
  • Dortmund, Germany|51.51494,7.466

Key Eligibility Criteria

  • Documented CLL/SLL requiring treatment according to iwCLL criteria
  • Age at least 18 years
  • At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromos…
  • Life expectancy ≥ six months

For full eligibility, visit ClinicalTrials.gov.

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