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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax | Experimental | Newly diagnosed AML patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacokinetic sampling | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasmatic dosage | Correlation of VEN plasma levels with inhibition of its Bcl-2 target | Before treatment |
| Plasmatic dosage | Correlation of VEN plasma levels with inhibition of its Bcl-2 target | At Day 5 of 1st round of chemotherapies |
| Plasmatic dosage | Correlation of VEN plasma levels with inhibition of its Bcl-2 target | At Day 9 of 1st round of chemotherapies |
| Plasmatic dosage | Correlation of VEN plasma levels with inhibition of its Bcl-2 target | At 12 months after start of treatment or at relapse whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Evaluate the overall survival | 1 year |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Cluzeau | CHU of Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital la Conception | Marseille | France | ||||
| CHU de Nice |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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| Vital status determination | Other | Survival situation 12 months after start of treament |
|
| Toxicity assessments | Other | Toxicity events |
|
| Venetoclax and azacitidine combination | Drug | Response to treatment |
|
| Nice |
| France |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |