A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia

Who is this study for? Patients with recurring chronic lymphocytic leukemia
What treatments are being studied? Venetoclax+Obinutuzumab
Status: Recruiting
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 + anti-CD20 antibody +/- X 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 treatment.

Locations
United States
California
Moores Cancer Center at UC San Diego /ID# 230157
RECRUITING
La Jolla
Iowa
Des Moines Oncology Research Association /ID# 232606
COMPLETED
Des Moines
Massachusetts
Dana-Farber Cancer Institute /ID# 230061
RECRUITING
Boston
Michigan
Henry Ford Hospital /ID# 230268
COMPLETED
Detroit
Minnesota
St. Lukes Hospital of Duluth /ID# 250021
RECRUITING
Duluth
Mississippi
Hattiesburg Clinic /ID# 233443
RECRUITING
Hattiesburg
North Carolina
University of North Carolina /ID# 233313
RECRUITING
Chapel Hill
Novant Health Presbyterian Medical Center /ID# 230201
RECRUITING
Charlotte
Novant Health Forsyth Medical Center /ID# 249533
RECRUITING
Winston-salem
New Jersey
Summit Medical Group-Florham Park /ID# 244782
COMPLETED
Florham Park
Regional Cancer Care Associates /ID# 244620
RECRUITING
Hackensack
Pennsylvania
Pennsylvania Oncology Hematolo /ID# 249637
RECRUITING
Philadelphia
Wisconsin
University of Wisconsin-Madiso /ID# 232612
RECRUITING
Madison
Other Locations
Australia
Royal Adelaide Hospital /ID# 229898
RECRUITING
Adelaide
Northern Hospital Epping /ID# 229847
RECRUITING
Epping
Peter MacCallum Cancer Ctr /ID# 254634
RECRUITING
Melbourne
Austria
Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569
RECRUITING
Leoben
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516
RECRUITING
Linz
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015
COMPLETED
Salzburg
Universitaetsklinikum St. Poelten /ID# 243493
RECRUITING
Sankt Pölten
Hanusch Krankenhaus /ID# 230010
RECRUITING
Vienna
Klinik Ottakring /ID# 230019
RECRUITING
Vienna
Medizinische Universitaet Wien /ID# 230013
RECRUITING
Vienna
Brazil
Hospital de Clinicas de Porto Alegre /ID# 243657
COMPLETED
Porto Alegre
Hospital Nove de Julho /ID# 243658
RECRUITING
São Paulo
Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659
RECRUITING
São Paulo
Bulgaria
UMHAT Sveti Georgi EAD /ID# 272321
RECRUITING
Plovdiv
MHAT Hristo Botev /ID# 229687
RECRUITING
Vratsa
Germany
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 248748
RECRUITING
Berlin
Onkologische Schwerpunktpraxis /ID# 245465
RECRUITING
Berlin
Duplicate_DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238
COMPLETED
Bremen
Universitaetsklinikum Koeln /ID# 230296
RECRUITING
Cologne
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168
RECRUITING
Dresden
Universitaetsklinikum Essen /ID# 230181
RECRUITING
Essen
Universitaetsklinikum Halle (Saale) /ID# 245350
RECRUITING
Halle
OncoResearch Lerchenfeld GmbH /ID# 230191
RECRUITING
Hamburg
Universitaetsklinikum des Saarlandes /ID# 248747
RECRUITING
Homburg
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186
RECRUITING
Kiel
Klinikum Landshut AdöR der Stadt Landshut /ID# 242991
RECRUITING
Landshut
VK&K Studien GbR /ID# 230198
RECRUITING
Landshut
Muenchen Klinik Schwabing /ID# 230197
COMPLETED
Munich
Stauferklinikum Schwaebisch Gmuend /ID# 230176
RECRUITING
Mutlangen
Bruederkrankenhaus St. Josef Paderborn /ID# 230177
RECRUITING
Paderborn
Universitaetsmedizin Rostock /ID# 230190
RECRUITING
Rostock
Universitaetsklinikum Ulm /ID# 230164
RECRUITING
Ulm
Israel
Hadassah /ID# 245059
RECRUITING
Jerusalem
Rabin Medical Center /ID# 243220
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center /ID# 243219
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 243218
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliera Santa Maria Terni /ID# 229442
RECRUITING
Terni
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504
RECRUITING
Turin
Romania
Fundeni Clinical Institute /ID# 241614
RECRUITING
Bucharest
Spain
Hospital Universitario de la Princesa /ID# 229665
RECRUITING
Madrid
United Kingdom
Blackpool Victoria Hospital /ID# 267280
RECRUITING
Blackpool
Leeds Teaching Hospitals NHS Trust /ID# 250732
RECRUITING
Leeds
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733
RECRUITING
Norwich
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2022-03-28
Estimated Completion Date: 2029-01
Participants
Target number of participants: 75
Treatments
Experimental: Cohort 1 - venetoclax + obinutuzumab
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
Experimental: Cohort 2 - venetoclax + obinutuzumab
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.
Sponsors
Collaborators: F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
Leads: AbbVie

This content was sourced from clinicaltrials.gov

Similar Clinical Trials