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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
EU CTIS ID: 2023-504036-17-00
What this study is testing
To evaluate the efficacy of venetoclax (Venclexa® or Venclyxto®) in combination with obinutuzumab (Gazyva® or Gazyvaro®) (VEN + G) compared with fludarabine, cyclophosphamide, and rituximab (FCR)/ bendamustine and rituximab (BR) on the basis of minimal residual disease (MRD) response rate
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.