A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation

Completed · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia (CLL)

In brief

This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale \[CIRS\]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).

Key facts

Study ID

NCT04285567

Run by

Hoffmann-La Roche

People needed

166

Starts

2020-05-28

Expected to finish

2025-03-19

Last updated by the study team

2026-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to comply with the study protocol, in the investigator's judgment
• Aged 18 years or older
• Have previously untreated documented Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
• CLL requiring treatment according to the iwCLL criteria
• Cumulative Illness Rating Scale (CIRS) score ≤ 6 and creatinine clearance (CrCl) ≥ 70 mL/min
• Hematology values within the following limits, unless cytopenia is caused by the underlying disease (i.e., no evidence of additional bone marrow (BM) dysfunction; e.g., myelodysplastic syndrome, hypoplastic BM):
• Absolute neutrophil count ≥ 1.0 x 109/L, unless there is BM involvement
• Platelet count ≥ 75 x 109/L and more than 7 days since last transfusion, or ≥ 30 x 109/L if there is BM involvement
• Adequate liver function as indicated by a total bilirubin, aspartate aminotransferase, and Alanine transaminase ≤ 2 times the institutional upper limit of normal (ULN) value, unless directly attributable to the participant's CLL
• Life expectancy >6 months
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm

You may not qualify if…

• Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL)
• Participants with Small Lymphocyclic Lymphoma (SLL) only
• Known central nervous system involvement
• Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
• Detected del(17p) or TP53 mutation (valid test within 6-months from screening is required for randomisation)
• An individual organ/system impairment score of 4 as assessed by the Cumulative Illness Rating Scale (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
• History of prior malignancy
• Participants with infections requiring IV treatment (Grade 3 or 4) within the last 8 weeks prior to enrollment
• Evidence of other clinically significant uncontrolled conditions including but not limited to active or uncontrolled systemic infection (e.g., viral, bacterial, or fungal)
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
• Hypersensitivity to fludarabine, bendamustine, cyclophosphamide, rituximab, obinutuzumab, or venetoclax or to any of the excipients (e.g., trehalose)
• Pregnant women and nursing mothers
• Vaccination with a live vaccine ≤ 28 days prior to randomization
• Prisoners or participants who are institutionalized by regulatory or court order or persons who are in dependence to the Sponsor or an investigator
• History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
• Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology)
• Positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
• Participants with known infection with HIV or Human T-Cell Leukemia Virus 1 (HTLV-1)
• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study
• Received any of the following agents within 28 days prior to the first dose of study treatment:
• Immunotherapy
• Radiotherapy
• Hormone therapy
• Any therapies intended for the treatment of lymphoma/leukemia whether approved or experimental

Where it is running

• Medical Center of Aurora — Aurora, Colorado, United States
• American Oncology Partners of Maryland, PA — Bethesda, Maryland, United States
• University of Tennessee Medical Center;Office of Clinical Trials — Knoxville, Tennessee, United States
• Oncology & Hematology Associates of Southwest Virginia, Inc._Goldschmidt — Roanoke, Virginia, United States
• Canberra Hospital — Canberra, Australian Capital Territory, Australia
• Liverpool Hospital — Liverpool, New South Wales, Australia
• Port Macquarie - Mid North Coast Cancer Institute — Port Macquarie, New South Wales, Australia
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• Monash Health;Haematology Research — Clayton, Victoria, Australia
• Peter MacCallum Cancer Centre;Clinical Haematology — Melbourne, Victoria, Australia
• Northern Hospital;Oncology and/or Hematology — Melbourne, Victoria, Australia
• Hopital Haut Leveque Chu de Bordeaux — Pessac, Aquitaine, France
• Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau;Hématologie et Thérapie Cellulaire — Tours, Indre-et-Loire, France
• Centre Hospitalier de Pérpignan;hématologie — Perpignan, Languedoc-Roussillon, France
• Hopital Claude Huriez - CHU de Lille;service maladies appareil digestif — Lille, Nord, France
• Centre Hospitalier intercommunal de Toulon La Seyne sur Mer — Toulon, Provence-Alpes-Côte d'Azur Region, France
• centre hospitalier lyon sud;Service Hématologie — Pierre-Bénite, Rhône, France
• HENRI MONDOR HOSPITAL;Centre d'investigation clinique — Créteil, Val-de-Marne, France
• Centre Hospitalier Universitaire de Caen Normandie — Caen, France
• Clinique Victor Hugo- CCS du Mans — Le Mans, France
• Centre Hospitalier Universitaire de Poitiers — Poitiers, France
• Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré;Hématologie Clinique — Reims, France
• Instituto Tumori Giovanni Paolo II;ONCOLOGIA MEDICA — Bari, Apulia, Italy
• Ospedale Vito Fazzi;U.O. Ematologia IV Piano Polo Oncologico — Lecce, Apulia, Italy

Full record on ClinicalTrials.gov

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