Spots Global Cancer Trial Database for Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)
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Trial Identification
Brief Title: Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)
Official Title: A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia
Study ID: NCT04895436
Conditions
Study Description
Brief Summary: Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide. Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moores Cancer Center at UC San Diego /ID# 230157, La Jolla, California, United States
Des Moines Oncology Research Association /ID# 232606, Des Moines, Iowa, United States
Dana-Farber Cancer Institute /ID# 230061, Boston, Massachusetts, United States
Henry Ford Health System /ID# 230268, Detroit, Michigan, United States
St. Luke's Hospital of Duluth /ID# 250021, Duluth, Minnesota, United States
Summit Medical Group-Florham Park /ID# 244782, Florham Park, New Jersey, United States
Regional Cancer Care Associates /ID# 244620, Hackensack, New Jersey, United States
Novant Health Presbyterian Medical Center /ID# 230201, Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 249533, Winston-Salem, North Carolina, United States
University of Wisconsin-Madiso /ID# 232612, Madison, Wisconsin, United States
Royal Adelaide Hospital /ID# 229898, Adelaide, South Australia, Australia
Northern Hospital Epping /ID# 229847, Epping, Victoria, Australia
Peter MacCallum Cancer Ctr /ID# 254634, Melbourne, Victoria, Australia
Universitaetsklinikum St. Poelten /ID# 243493, Sankt Poelten, Niederoesterreich, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516, Linz, Oberoesterreich, Austria
Medizinische Universitaet Wien /ID# 230013, Vienna, Wien, Austria
Klinik Ottakring /ID# 230019, Vienna, Wien, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015, Salzburg, , Austria
Hanusch Krankenhaus /ID# 230010, Wien, , Austria
Hospital de Clinicas de Porto Alegre /ID# 243657, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Nove de Julho /ID# 243658, São Paulo, Sao Paulo, Brazil
Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659, Sao Paulo, , Brazil
MHAT Hristo Botev /ID# 229687, Vratsa, , Bulgaria
Stauferklinikum Schwaebisch Gmuend /ID# 230176, Mutlangen, Baden-Wuerttemberg, Germany
Universitaetsklinikum Ulm /ID# 230164, Ulm, Baden-Wuerttemberg, Germany
VK&K Studien GbR /ID# 230198, Landshut, Bayern, Germany
Universitaetsklinikum Koeln /ID# 230296, Köln, Nordrhein-Westfalen, Germany
Gemeinschaftspraxis Haematologie - Onkologie BAG /ID# 230168, Dresden, Sachsen-Anhalt, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186, Kiel, Schleswig-Holstein, Germany
Onkologische Schwerpunktpraxis /ID# 245465, Berlin, , Germany
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 248748, Berlin, , Germany
DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238, Bremen, , Germany
Universitaetsklinikum Essen /ID# 230181, Essen, , Germany
Universitaetsklinikum Halle (Saale) /ID# 245350, Halle (Saale), , Germany
OncoResearch Lerchenfeld GmbH /ID# 230191, Hamburg, , Germany
Universitaetsklinikum des Saarlandes /ID# 248747, Homburg, , Germany
Klinikum Landshut AdöR der Stadt Landshut /ID# 242991, Landshut, , Germany
Muenchen Klinik Schwabing /ID# 230197, Muenchen, , Germany
Bruederkrankenhaus St. Josef Paderborn /ID# 230177, Paderborn, , Germany
Universitaetsmedizin Rostock /ID# 230190, Rostock, , Germany
The Chaim Sheba Medical Center /ID# 243219, Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 243218, Tel Aviv, Tel-Aviv, Israel
Hadassah /ID# 245059, Jerusalem, Yerushalayim, Israel
Rabin Medical Center /ID# 243220, Haifa, , Israel
AOU Citta della Salute e della Scienza di Torino /ID# 229504, Torino, Piemonte, Italy
Azienda Ospedaliera Santa Maria Terni /ID# 229442, Terni, , Italy
Fundeni Clinical Institute /ID# 241614, Bucharest, Bucuresti, Romania
Hospital Universitario de la Princesa /ID# 229665, Madrid, , Spain
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733, Norwich, Norfolk, United Kingdom
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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