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| Name | Class |
|---|---|
| Fédération Leucémie Espoir | UNKNOWN |
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This is a prospective, multicenter, clinical-biological cohort study. Its objective is to assess the pharmacokinetics-pharmacodynamics (PK-PD) of venetoclax (VEN) in patients with Acute Myeloid Leukemia (AML).
This study involves only minimal risks and constraints related to the collection of biological samples (blood samples for PK testing) and the collection of clinical data. Therapeutic management of patients participating in this study is not changed. A total of 100 patients will be included in the study over a 12-month period. A maximum of 21 additional samples are planned, with a maximum of 12 mL of blood per sampling day (4 mL at each sampling time) for PK dosing of venetoclax.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with acute myeloid leukaemia receiving venetoclax-azicitine as first line | Experimental | Blood samples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacokinetic dosages of venetoclax | Other | Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint | To assess PK exposure parameters : AUC (area under the curve) of venetoclax at steady state | From the first day of venetoclax administration to end of the treatment (days) |
| Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint | To assess PK exposure parameters : Minimal Concentration (Cmin) of venetoclax at steady state | From the first day of venetoclax administration to end of the treatment (days) |
| Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint | To assess PK exposure parameters : Peak Plasma Concentration (Cmax) of venetoclax at steady state | From the first day of venetoclax administration to end of the treatment (days) |
| Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint | To assess PK exposure parameters : Equilibrium concentration (Css) of venetoclax at steady state | From the first day of venetoclax administration to end of the treatment (days) |
| Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Clinical Endpoint | Proportion of patients with a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) or partial remission (PR) or no remission | From the first day of venetoclax administration up to day 28 (end of the first venetoclax cure) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess relationship between different PK markers of venetoclax and its clinical efficacy. | Correlation between PK exposure parameters (including Cmin, Cmax, Css) of venetoclax and clinical outcome (cytologic response at cycle 6, survival without progression and overall survival). | From the first day of venetoclax administration and through study completion, at least 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the relationship between plasmatic venetoclax exposition and response to treatment | To assess correlation between minimal concentration of venetoclax and minimal residual disease | From the first day of venetoclax administration to through the study, at least 24 months |
| To assess the relationship between plasmatic venetoclax exposition and response to treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michaël Philippe | Contact | +33478782666 | michael.philippe@lyon.unicancer.fr | |
| Amine Belhabri, MD | Contact | amine.belhabri@lyon.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Pierre Oudot | Recruiting | Bourgoin | France | France |
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Clinical-biological cohort
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| To assess correlation between plasmatic exposition to venetoclax and occurrence of adverse events | Correlation between PK exposure parameters (including Cmin, Cmax, Css) of venetoclax and occurence of adverse events grade equal or superior to 3 related to venetoclax/azacitidine and their impact on treatment administration | From the the first day of venetoclax administration to the last day (Day 168) of venetoclax administration |
| To assess inter-individual and intra-individual variability in plasma exposure to venetoclax. | Coefficient of variation of AUC and Cmin at steady state for venetoclax | From the first day of ventoclax administration and nd through study completion, at least 24 months |
To assess correlation between Peak Plasma Concentration (Cmax) of venetoclax and minimal residual disease |
| From the first day of venetoclax administration to through the study, at least 24 months |
| To assess the relationship between plasmatic venetoclax exposition and response to treatment | To assess correlation between Equilibrium concentration of venetoclax (Css) and minimal residual disease | From the first day of venetoclax administration to through the study, at least 24 months |
| To assess interaction between azole antifungals and venetoclax | Number of patients treated or not treated by an azole antifungal | From the the first day of venetoclax administration to the last day (Day 168) of venetoclax administration |
| CHU de Grenoble | Recruiting | Grenoble | 38000 | France |
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| Centre Leon Berard | Recruiting | Lyon | 69008 | France |
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| CHU de Saint-Étienne | Recruiting | Saint-Etienne | 42100 | France |
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| Hôpitaux Nord-Ouest - Villefranche-sur-Saône | Recruiting | Villefranche-sur-Saône | 69400 | France |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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