Chronic Lymphocytic Leukemia Clinical Trial

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)

Summary

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess how well venetoclax + obinutuzumab (VenG) works and how safe they are in adult participants with CLL who were previously treated with VenG. 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 treatment arms, based on when symptoms of CLL came back after previous treatment with VenG. Approximately 75 adult participants with CLL who have been treated with VenG 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.
Previously completed venetoclax + obinutuzumab (VenG) regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission.
More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L VenG treatment.

Exclusion Criteria:

- Received intervening treatment for CLL after previous treatment with VenG.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT04895436

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 50 Locations for this study

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Moores Cancer Center at UC San Diego /ID# 230157
La Jolla California, 92093, United States
Des Moines Oncology Research Association /ID# 232606
Des Moines Iowa, 50309, United States
Dana-Farber Cancer Institute /ID# 230061
Boston Massachusetts, 02215, United States
Henry Ford Health System /ID# 230268
Detroit Michigan, 48202, United States
St. Luke's Hospital of Duluth /ID# 250021
Duluth Minnesota, 55805, United States
Summit Medical Group-Florham Park /ID# 244782
Florham Park New Jersey, 07932, United States
Novant Health Presbyterian Medical Center /ID# 230201
Charlotte North Carolina, 28204, United States
Novant Health Forsyth Medical Center /ID# 249533
Winston-Salem North Carolina, 27103, United States
Fox Chase Cancer Center /ID# 246851
Philadelphia Pennsylvania, 19111, United States
University of Wisconsin-Madiso /ID# 232612
Madison Wisconsin, 53705, United States
Royal Adelaide Hospital /ID# 229898
Adelaide South Australia, 5000, Australia
Northern Hospital Epping /ID# 229847
Epping Victoria, 3076, Australia
Universitaetsklinikum St. Poelten /ID# 243493
Sankt Poelten Niederoesterreich, 3100, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516
Linz Oberoesterreich, 4010, Austria
Medizinische Universitaet Wien /ID# 230013
Vienna Wien, 1090, Austria
Klinik Ottakring /ID# 230019
Vienna Wien, 1160, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 230015
Salzburg , 5020, Austria
Hanusch Krankenhaus /ID# 230010
Wien , 1140, Austria
Hospital de Clinicas de Porto Alegre /ID# 243657
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Instituto de Ensino e Pesquisa Sao Lucas /ID# 243659
Sao Paulo , 01236, Brazil
Hospital Nove de Julho /ID# 243658
São Paulo , 01409, Brazil
MHAT Hristo Botev /ID# 229687
Vratsa , 3000, Bulgaria
Stauferklinikum Schwaebisch Gmuend /ID# 230176
Mutlangen Baden-Wuerttemberg, 73557, Germany
Universitaetsklinikum Ulm /ID# 230164
Ulm Baden-Wuerttemberg, 89081, Germany
VK&K Studien GbR /ID# 230198
Landshut Bayern, 84036, Germany
Onkologische Kooperation Harz /ID# 230235
Goslar Niedersachsen, 38642, Germany
Universitaetsklinikum Koeln /ID# 230296
Köln Nordrhein-Westfalen, 50937, Germany
Gemeinschaftspraxis Haematologie - Onkologie BAG /ID# 230168
Dresden Sachsen-Anhalt, 01307, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186
Kiel Schleswig-Holstein, 24105, Germany
Onkologische Schwerpunktpraxis /ID# 245465
Berlin , 10707, Germany
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 248748
Berlin , 13353, Germany
DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238
Bremen , 28239, Germany
Universitaetsklinikum Essen /ID# 230181
Essen , 45147, Germany
Universitaetsklinikum Halle (Saale) /ID# 245350
Halle (Saale) , 06120, Germany
OncoResearch Lerchenfeld GmbH /ID# 230191
Hamburg , 22081, Germany
Institut für Versorgungsforschung in der Onkologie GbR /ID# 230241
Koblenz , 56068, Germany
Klinikum Landshut gGmbH /ID# 242991
Landshut , 84034, Germany
Muenchen Klinik Schwabing /ID# 230197
Muenchen , 80804, Germany
Bruederkrankenhaus St. Josef Paderborn /ID# 230177
Paderborn , 33098, Germany
Universitaetsmedizin Rostock /ID# 230190
Rostock , 18057, Germany
The Chaim Sheba Medical Center /ID# 243219
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 243218
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Hadassah /ID# 245059
Jerusalem , 91120, Israel
Rabin Medical Center /ID# 243220
Petakh Tikva , 49414, Israel
Azienda Ospedaliera Santa Maria Terni /ID# 229442
Terni , 05100, Italy
A.O.U. Citta della Salute e della Scienza di Torino /ID# 229504
Turin , 10126, Italy
Institutul Clinic Fundeni /ID# 241614
Bucharest , 92520, Romania
Hospital Universitario de la Princesa /ID# 229665
Madrid , 28006, Spain
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733
Norwich Norfolk, NR4 7, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 250732
Leeds , LS9 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT04895436

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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