Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 participa...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2025
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04285567
Start Date
May 28 2020
End Date
March 19 2025
Last Update
October 8 2025
Active Locations (40)
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1
Medical Center of Aurora
Aurora, Colorado, United States, 80012
2
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States, 20817
3
University of Tennessee Medical Center;Office of Clinical Trials
Knoxville, Tennessee, United States, 37920
4
Oncology & Hematology Associates of Southwest Virginia, Inc._Goldschmidt
Roanoke, Virginia, United States, 24014