Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Myeloid Leukemia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Multicenter, prospective, interventional, single arm studyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young (age ?65 years) patients with CLL. However, IGVH unmutated patients and patients with disrupted TP53 show an inferior outcome after FCR in terms of PFS and OS. Venetoclax as a single agent or combined with rit...
Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young (age ?65 years) patients with CLL. However, IGVH unmutated patients and patients with disrupted TP53 show an inferior outcome after FCR in terms of PFS and OS. Venetoclax as a single agent or combined with rituximab is an effective treatment for relapsed/refractory patients with IGVH unmutated CLL and/or del(17p) and is associated with a high rate of clinical responses and MRD-negative responses. The achievement of a MRD negative response in CLL is the best treatment endpoint since it is associated with an improved PFS. In treatment-naive patients with unmutated IGVH and/or disrupted TP53 the venetoclax and rituximab combination could be a more effective regimen than FCR with a 15% increase in the CR rate.
Tracking Information
- NCT #
- NCT03455517
- Collaborators
- Not Provided
- Investigators
- Study Chair: Roberto Foà Università degli Studi di Roma "Sapienza" Study Director: Francesca Romana Mauro Università degli Studi di Roma "Sapienza"
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