A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL

Status: Recruiting
Location: See all (70) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. 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:

• Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of \> 6 months.

• Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation.

• Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.

• Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol.

• Creatinine clearance (CrCl) \>= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion.

Locations
United States
Arizona
Arizona Oncology - Tucson - Rudasill /ID# 267552
RECRUITING
Tucson
Southern VA Health Care System /ID# 266254
RECRUITING
Tucson
California
UCSF FRESNO/Community Cancer Institute /ID# 270874
RECRUITING
Clovis
Valkyrie Clinical Trials /ID# 268151
RECRUITING
Los Angeles
Colorado
Rocky Mountain Cancer Centers - Aurora /ID# 267549
RECRUITING
Aurora
Connecticut
Yale University School of Medicine /ID# 266224
RECRUITING
New Haven
Florida
Malcolm Randall V.A. Medical Center /ID# 267825
RECRUITING
Gainesville
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713
RECRUITING
Jacksonville
Mid Florida Hematology And Oncology Center /ID# 269159
RECRUITING
Orange City
Comprehensive Hematology Oncology /ID# 267644
RECRUITING
St. Petersburg
Iowa
University of Iowa Health Care /ID# 267206
RECRUITING
Des Moines
Illinois
Springfield Clinic - First /ID# 270145
RECRUITING
Springfield
Indiana
Northwest Cancer Center - Dyer Clinic /ID# 268478
RECRUITING
Dyer
Louisiana
Willis-Knighton Medical Center /ID# 270569
RECRUITING
Shreveport
Massachusetts
UMass Memorial Medical Center /ID# 270023
RECRUITING
Worcester
Maryland
Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 266445
RECRUITING
Bethesda
Maryland Oncology Hematology - Silver Spring /ID# 267557
RECRUITING
Silver Spring
Michigan
Henry Ford Hospital /ID# 270973
RECRUITING
Detroit
Missouri
Saint Lukes Hospital of Kansas City /ID# 267270
RECRUITING
Kansas City
North Carolina
Atrium Health /ID# 267219
RECRUITING
Charlotte
Atrium Health Wake Forest Baptist Medical Center /ID# 273142
RECRUITING
Winston-salem
New York
Icahn School of Medicine at Mount Sinai /ID# 266328
RECRUITING
New York
Ohio
Cleveland Clinic Main Campus /ID# 271292
RECRUITING
Cleveland
Oklahoma
Oklahoma Cancer Specialists and Research Institute /ID# 267643
RECRUITING
Tulsa
Oregon
Willamette Valley Cancer Institute and Research Center /ID# 266326
RECRUITING
Eugene
Rhode Island
Lifespan Cancer Institute - Providence /ID# 266550
RECRUITING
Providence
Texas
Texas Oncology - Austin Midtown /ID# 268152
RECRUITING
Austin
University of Texas - Southwestern Medical Center /ID# 266528
RECRUITING
Dallas
Virginia
Virginia Cancer Specialists - Gainesville /ID# 268155
RECRUITING
Gainesville
Washington
Vista Oncology - East Olympia /ID# 267337
RECRUITING
Olympia
Northwest Medical Specialties Tacoma /ID# 266327
RECRUITING
Tacoma
West Virginia
West Virginia University School of Medicine /ID# 267645
RECRUITING
Morgantown
Other Locations
Australia
St Vincent's Hospital - Melbourne /ID# 270027
RECRUITING
Fitzroy
Royal Perth Hospital /ID# 266906
RECRUITING
Perth
Townsville University Hospital /ID# 266954
RECRUITING
Townsville
Calvary Mater Newcastle /ID# 267408
RECRUITING
Waratah
France
CHU Amiens-Picardie Site Sud /ID# 266849
RECRUITING
Amiens
Centre Hospitalier d Argenteuil Victor Dupouy /ID# 266322
RECRUITING
Argenteuil
Centre Hospitalier de la Côte Basque /ID# 266847
RECRUITING
Bayonne
Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 266854
RECRUITING
Chambéry
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 266270
RECRUITING
Créteil
Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy /ID# 266852
RECRUITING
Metz
Centre Antoine-Lacassagne /ID# 266894
RECRUITING
Nice
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 266272
RECRUITING
Orléans
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 267438
RECRUITING
Paris
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 266319
RECRUITING
St-priest-en-jarez
Greece
University General Hospital of Alexandroupoli /ID# 266816
RECRUITING
Alexandroupoli
Evangelismos Hospital /ID# 266815
RECRUITING
Athens
General Hospital of Athens Laiko /ID# 266813
RECRUITING
Athens
University General Hospital Attikon /ID# 266814
RECRUITING
Athens
Olympion General Clinic /ID# 266819
RECRUITING
Pátrai
Puerto Rico
Pan American Center for Oncology Trials /ID# 266243
RECRUITING
Rio Piedras
Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 266567
RECRUITING
Belgrade
Clinical Hospital Center Zvezdara /ID# 266560
RECRUITING
Belgrade
University Clinical Center Serbia /ID# 266579
RECRUITING
Belgrade
Institute for Oncology of Vojvodina /ID# 266556
RECRUITING
Kamenitz
University Clinical Center Kragujevac /ID# 266568
RECRUITING
Kragujevac
University Clinical Center Nis /ID# 266580
RECRUITING
Niš
University Clinical Center Vojvodina /ID# 266674
RECRUITING
Novi Sad
Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 266969
RECRUITING
Madrid
Hospital MD Anderson Cancer Center Madrid /ID# 267167
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 266967
RECRUITING
Majadahonda
Clinica Universidad de Navarra - Pamplona /ID# 267762
RECRUITING
Pamplona
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 267164
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocio /ID# 266968
RECRUITING
Seville
Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 267046
RECRUITING
Kaohsiung City
China Medical University Hospital /ID# 267018
RECRUITING
Taichung
National Taiwan University Hospital /ID# 267017
RECRUITING
Taipei City
Linkou Chang Gung Memorial Hospital /ID# 267045
RECRUITING
Taoyuan
United Kingdom
Nottingham City Hospital /ID# 266991
RECRUITING
Nottingham
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2028-03
Participants
Target number of participants: 120
Treatments
Experimental: Arm A: Venetoclax + Obinutuzumab
Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up.
Experimental: Arm B: Venetoclax + Acalabrutinib
Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up.
Experimental: Arm C: Venetoclax + Acalabrutinib
Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A.
Experimental: Arm D: Venetoclax + Acalabrutinib
Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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