Chronic Lymphocytic Leukemia
Conditions
Brief summary
To evaluate in young CLL patients with an adverse biologic profile: 1. The benefit of front-line therapy with Venetoclax and Obinutuzumab (VenObi) in terms of rate of patients with uMRD by ASO-PCR in the PB and BM measured at the end of combination therapy (EOCT month 9)., To evaluate in young CLL patients with an adverse biologic profile: The benefit of adding Zanubrutinib to Venetoclax (VenZan) in terms of rate of patients with uMRD by ASO-PCR in the PB and BM in patients with residual disease at the EOCT with VenObi (month 21).
Detailed description
The benefit of front-line therapy with Venetoclax and Obinutuzumab (VenObi) in terms of rate of patients with uMRD by flow-cytometry in the PB and BM measured at the end of combination therapy (EOCT month 9)., The benefit of treatment with VenObi+Ven in terms of rate of patients with uMRD, L-MRD and H-MRD in the PB and BM at month 15, 21, 27, 33, 36 by: a. ASO-PCR b. Flow-cytometry, The benefit of treatment with VenObi+VenZan in terms of rate of patients with uMRD, L-MRD and H-MRD in the PB and BM at month 15, 21, 27, 33, 36 by: a. ASO-PCR b. Flow-cytometry 4. Rate of patients with uMRD according to the clinical and the biologic characteristics of CLL, Rate of patients with uMRD according to the clinical and the biologic characteristics of CLL, Progression Free Survival (PFS) at 36 months, Overall Survival (OS) at 36 months, Survival outcomes (OS and PFS) estimates at 36 months according to the: a. levels of MRD (uMRD, L-MRD, H-MRD); b. response (CR, PR, stable disease); c. treatment (Ven-Obi+Ven or VenObi+VenZan); d. the clinical and the biologic characteristics of CLL (CD38, CD49d, IGHV, FISH profile, mutations of TP53, NOTCH1, BIRC3, SF3B1), The benefit of treatment with VenObi+Ven or VenObi+VenZan on the improvement of Hb value, granulocyte, and platelet counts and immunoglobulin levels., The toxicity profile of treatment in terms of AE/SAE.
Interventions
DRUGPARACETAMOL
DRUGDEXAMETHASONE PHOSPHATE
DRUGVENETOCLAX
DRUGBactrim 160 mg + 800 mg compresse
DRUGALLOPURINOL
DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.
DRUGLamivudina Mylan 150 mg compresse rivestite con film
DRUGCHLORPHENAMINE MALEATE
Sponsors
Fondazione Gimema Franco Mandelli Onlus
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate in young CLL patients with an adverse biologic profile: 1. The benefit of front-line therapy with Venetoclax and Obinutuzumab (VenObi) in terms of rate of patients with uMRD by ASO-PCR in the PB and BM measured at the end of combination therapy (EOCT month 9)., To evaluate in young CLL patients with an adverse biologic profile: The benefit of adding Zanubrutinib to Venetoclax (VenZan) in terms of rate of patients with uMRD by ASO-PCR in the PB and BM in patients with residual disease at the EOCT with VenObi (month 21). | — |
Secondary
| Measure | Time frame |
|---|---|
| The benefit of front-line therapy with Venetoclax and Obinutuzumab (VenObi) in terms of rate of patients with uMRD by flow-cytometry in the PB and BM measured at the end of combination therapy (EOCT month 9)., The benefit of treatment with VenObi+Ven in terms of rate of patients with uMRD, L-MRD and H-MRD in the PB and BM at month 15, 21, 27, 33, 36 by: a. ASO-PCR b. Flow-cytometry, The benefit of treatment with VenObi+VenZan in terms of rate of patients with uMRD, L-MRD and H-MRD in the PB and BM at month 15, 21, 27, 33, 36 by: a. ASO-PCR b. Flow-cytometry 4. Rate of patients with uMRD according to the clinical and the biologic characteristics of CLL, Rate of patients with uMRD according to the clinical and the biologic characteristics of CLL, Progression Free Survival (PFS) at 36 months, Overall Survival (OS) at 36 months, Survival outcomes (OS and PFS) estimates at 36 months according to the: a. levels of MRD (uMRD, L-MRD, H-MRD); b. response (CR, PR, stable disease); c. treatment ( | — |
Countries
Italy
Outcome results
None listed