The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these analyses will be correlated with treatment toxicity, response rate and overall patient survival. This pilot study will highlight the inter-individual variability of this AZA + VEN combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
4 blood withdrawals ( before treatment, Day 5, Day 9 and relapse or 12 months after start of treatment) for the plasma dosage of VEN and inhibition of its Bcl-2
Survival situation 12 months after start of treament
Toxicity events
Response to treatment
Hopital la Conception
Marseille, France
CHU de Nice
Nice, France
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time frame: Before treatment
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time frame: At Day 5 of 1st round of chemotherapies
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time frame: At Day 9 of 1st round of chemotherapies
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time frame: At 12 months after start of treatment or at relapse whichever comes first
Overall survival
Evaluate the overall survival
Time frame: 1 year
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