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

STATUS

Recruiting
participants needed

165
sponsor

Hoffmann-La Roche

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Updated on 19 February 2024

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blood transfusion

platelet count

absolute neutrophil count

neutrophil count

cyclophosphamide

chronic lymphocytic leukemia

rituximab

lymphoid leukemia

fludarabine

leukemia

bendamustine

bone marrow procedure

venetoclax

lymphocytic leukemia

cytopenia

obinutuzumab

17p deletion

myelodysplastic syndrome

Summary

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).

Details

Condition	Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia
Age	18years - 100years
Treatment	Cyclophosphamide, Fludarabine, Rituximab, Bendamustine, Obinutuzumab, Venetoclax
Clinical Study Identifier	NCT04285567
Sponsor	Hoffmann-La Roche
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
Exclusion Criteria
	Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL)
	Participants with Small Lymphocyclic Lymphoma (SLL)
	Known central nervous system involvement
	Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
	Detected del (17p) or TP53 mutation
	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
	Participants who have received the following agents
	Strong and moderate CYP3A inhibitors/inducers within 7 days prior to the initiation of study treatment
	Steroid therapy for anti-neoplastic intent with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids within 7 days prior to the first dose of study drug administration
	Consumed grapefruit, grapefruit products, Seville oranges(including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug and throughout venetoclax administration
	Inability to swallow a large number of tablets

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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