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Studies

Interventional Active not recruiting Phase 2

NCT04883749 on ClinicalTrials.gov

Efficacy of Acalabrutinib in Very Old or Frail Patients With Treatment-naïve or Relapsed/Refractory CLL

Official title: CLL-Frail - A Prospective, Multicenter Phase II Trial of Acalabrutinib in Very Old (≥80y) or Frail CLL-Patients

  • Sponsor: German CLL Study Group
  • Enrollment: 53 (Actual)
  • Study start: 2021-06-01 (Actual)
  • Primary completion: 2023-07-31 (Actual)
  • Study completion: 2024-12-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

The aim of this trial is to show the efficacy, safety and feasibility of acalabrutinib in a cohort of CLL-patients ≥80 years or with a FRAIL scale score \>2 (5-item questionnaire to be filled out by the patient)

Conditions

  • Chronic Lymphoid Leukemia

Intervention / Treatment

  • Biological: Acalabrutinib

Primary Outcome Measures

  • Overall response rate (ORR) at initial response assessment (At initial response assessment (approx. 6 months after initiation of therapy))
    Proportion of patients having achieved complete response (CR), complete response with incomplete bone marrow recovery (CRi) or partial response (PR) as response (according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines)

Countries

Austria, Germany

Locations and Investigators

  • Medizinische Universitaet Innsbruck, Innsbruck, Austria
    • Jan-Paul, Bohn
  • Hanusch Krankenhaus Der Wiener Gebietskrankenkasse, Vienna, Austria
    • Thomas, Nösslinger
  • Gemeinschaftspraxis für Hämatologie und Onkologie, Magdeburg, Germany
    • Kathleen, Jentsch-Ullrich
  • Universitaetsklinikum Essen AöR, Essen, Germany
    • Stephanie, Sasse
  • Institut Fuer Versorgungsforschung In Der Onkologie GbR, Koblenz, Germany
    • Geothy, Chakupurakal
  • Dr. Vehling-Kaiser MVZ GmbH, Landshut, Germany
    • Ursula, Vehling-Kaiser
  • OncoResearch Lerchenfeld GmbH, Hamburg, Germany
    • Thomas, Wolff
  • DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU, Deggendorf, Germany
    • Christian, Spoer
  • University Hospital Cologne AöR, Cologne, Germany
    • Barbara, Eichhorst
  • Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, Germany
    • Ingo, Schwaner
  • MVZ fuer Haematologie und Onkologie Ravensburg GmbH, Ravensburg, Germany
    • Thomas, Decker
  • Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH, Paderborn, Germany
    • Tobias, Gaska
  • Mediprojekt GbR, Hannover, Germany
    • Michael, Gärtner
  • Gemeinschaftspraxis für Hämatologie und Onkologie, Muenster, Germany
    • Rüdiger, Liersch
  • Haematologisch Onkologische Schwerpunktpraxis, Wuerzburg, Germany
    • Björn, Schöttker
  • Universitaetsklinikum Schleswig-Holstein AöR, Kiel, Germany
    • Matthias, Ritgen

Study Officials