Select Your Region
Americas
Europa
Afrika
Weltweit
Eine vergleichende Studie zur Wirksamkeit und Sicherheit von Obinutuzumab + Venetoclax (GDC-0199) gegenüber Obinutuzumab + Chlorambucil bei Teilnehmenden mit chronischer lymphatischer Leukämie
Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients 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
- Esslingen am Neckar
- Frankfurt (Oder)
- Freiburg im Breisgau
- Göttingen
- Heidelberg
- Herne
- Koblenz
- Köln
- Landshut
- Mutlangen
- Mönchengladbach
- München
- Neunkirchen
- Paderborn
- Regensburg
- Stuttgart
- Tübingen
- Ulm
- Weiden in der Oberpfalz
Studien-ID:
NCT02242942 2014-001810-24 BO25323
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
Um die aktuellste Version dieser Seite aufzurufen gehen Sie bitte auf www.Klinische-studien-für-patienten.de
