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 mutatio

Phase 1

Conditions: Chronic Lymphocytic Leukemia (CLL)
MedDRA version: 21.0Level: LLTClassification code: 10008976Term: Chronic lymphocytic leukemia Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-504036-17-00

Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 166

Inclusion Criteria

Aged 18 years or older, Have previously untreated documented CLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, Cumulative illness rating scale score <=6 and creatinine clearance >=70 mL/min as calculated by the Standard Cockcroft and Gault Formula, Hematology values within the following limits, unless cytopenia is caused by the underlying disease (i.e., no evidence of additional BM dysfunction; e.g., myelodysplastic syndrome, hypoplastic BM): o Absolute neutrophil count >=1.0 × 109/L, unless there is BM involvement o Platelet count >=75 × 109/L and more than 7 days since last transfusion, or >=30 × 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 value, unless directly attributable to the patient’s CLL, Life expectancy >6 months

Exclusion Criteria

Transformation of CLL to aggressive non-Hodgkin’s lymphoma, Patients with small lymphocyclic lymphoma (SLL) only (a diagnosis of CLL/SLL is permitted), Known central nervous system involvement, Patients with a history of confirmed progressive multifocal leukoencephalopathy, Detected del (17p) or TP53 mutation (valid test within 6-months from screening is required for randomization), 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