Rituximab, Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL
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|ClinicalTrials.gov Identifier: NCT03567876|
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : February 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Mantle-Cell||Drug: Venetoclax||Phase 2|
The aim of the study is to improve long term results of R-BAC, consolidating patients with high-risk (HR) features (defined as: elevated Ki67 and/or blastoid cytology and/or TP53 mutation after central pathology review) with Venetoclax (ABT-199), which has demonstrated relevant single agent activity in relapsed/refractory MCL in a Phase 1-2 trial.
The updated Progression Free Survival curves of the R-BAC500 trial has shown that the expected 2-years PFS for patients with HR disease is 40% (H0), as compared to low-risk patients (LR) that have a 2-years PFS of 100%. The addition of Venetoclax to HR patients after R-BAC is expected to improve results and efficacy of this regimen in this "difficult -to- treat" population, that represents approximately 40-45 % of newly diagnosed elderly patients with MCL. It appears reasonable to treat with the experimental drug also LR patients that do not respond appropriately (less than CR) at the end of R-BAC. Since the number of such LR patients is hardly predictable based on the present experience with R-BAC500 trial, the analysis of this sub-cohort will be of exploratory nature, and thus assessed separately.
The study objective is to evaluate whether the addition of venetoclax after R-BAC to HR patients improves the results of the standard R-BAC, in terms of Progression Free Survival .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rituximab, Bendamustine and Cytarabine Followed by Venetoclax (V-RBAC) in High-risk Elderly Patients With Mantle Cell Lymphoma (MCL)|
|Actual Study Start Date :||September 3, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2025|
Experimental: V-RBAC (RBAC followed by Venetoclax)
Induction phase: RBAC --> up to 6 cycles for low risk (LR) patients and up to 4 cycles for high risk (HR) patients.
Patients proceeding to Venetoclax treatment will receive consolidation with single agent Venetoclax 800 mg/die x 4 28d cycles (with initial ramp-up dose) of each consolidation cycle. Consolidation will be followed by maintenance with single agent Venetoclax 400 mg/die (V maint ) for a total of 2 years (4 months consolidation+20 months maintenance).
Consolidation and maintenance phases with Venetoclax (for a total of 2 years) after an induction phase R-BAC (up to 6 cycles for law risk patients and up to 4 cycles for high risk patients)
Other Name: Venclyxto (commercial name)
- Progression-free survival of the High Risk patients [ Time Frame: 24 months ]2-years progression-free survival (PFS) of the HR patients from date of enrollment
- Molecular response [ Time Frame: 10 months and 30 months ]The proportion of molecular response (analyzed in the labs of the FIL- MRD Network)
- Progression-free survival of all patients and different subgroups [ Time Frame: 24 months ]The progression-free survival (PFS) of all enrolled patients, and of different subgroups (i.e TP53 mutated patients)
- Overall survival [ Time Frame: 54 months ]Overall survival
- Duration of responses [ Time Frame: 24 months ]Duration of responses
- Proportion of complete remission in High Risk and Law Risk patients [ Time Frame: 6 months and 10 months ]The proportion of complete remission (CR) before and after venetoclax in the HR group and/or in the LR not responding to R-BAC
- Completed expected treatment schedule [ Time Frame: 30 months ]The proportion of patients that complete the expected treatment schedule
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 10 months and 30 months ]The proportion of patients with adverse events as assessed by CTCAE 4.03 during venetoclax administration as consolidation or maintenance after R-BAC
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567876
|Contact: Claudia Peracchiofirstname.lastname@example.org|
|Contact: Antonella Ferrantiemail@example.com|
|Principal Investigator:||Carlo Visco, MD||AOU Integrata di Verona - U.O. Ematologia -Verona -Italy|