A clinical study to compare obinutuzumab in combination with venetoclax and obinutuzumab in combination with chlorambucil in people with previously untreated chronic lymphocytic leukaemia who have other medical conditions

A Study to Compare the Efficacy and Safety of Obinutuzumab + Venetoclax (GDC-0199) Versus Obinutuzumab + Chlorambucil in Participants With Chronic Lymphocytic Leukemia

  • Krebs
  • Leukämie
  • Chronische lymphatische Leukämie
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:

Aktiv, keine Rekrutierung

Diese Studie läuft in
Städte
  • Aachen
  • Amberg
  • Berlin
  • Dresden
  • Essen
  • Frankfurt (Oder)
  • Freiburg im Breisgau
  • Göttingen
  • Heidelberg
  • Herne
  • Koblenz
  • Köln
  • Landshut
  • Mönchengladbach
  • München
  • Neunkirchen
  • Paderborn
  • Regensburg
  • Stuttgart
  • Tübingen
  • Ulm
Studien-ID:

NCT02242942 2014-001810-24 BO25323

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      Studienzusammenfassung

      This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02242942, BO25323, 2014-001810-24 Studien-ID
      Chlorambucil, Venetoclax, Obinutuzumab Treatments
      Lymphocytic Leukemia, Chronic Condition
      Official Title

      A prospective, open-label, multicenter, randomized phase III trial to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax (GDC-0199/ABT-199) versus obinutuzumab and chlorambucil in previously untreated patients with CLL and coexisting medical conditions

      Einschlusskriterien

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
      • CLL requiring treatment according to IWCLL criteria
      • Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 6
      • Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL
      • Adequate liver function
      • Life expectancy > 6 months
      • Agreement to use highly effective contraceptive methods per protocol
      Exclusion Criteria
      • Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia)
      • Known central nervous system involvement
      • Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
      • An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
      • Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
      • Inadequate renal function
      • History of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy
      • Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration
      • Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
      • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
      • Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients
      • Pregnant women and nursing mothers
      • Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology) or positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
      • Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1)
      • Requires the use of warfarin, marcumar, or phenprocoumon
      • Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug

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