CD123 positive Acute Myeloid Leukemia
Conditions
Brief summary
Dose Escalation (Regimens A-C): RP2D of IMGN632 when administered in combination with azacitidine (Regimen A) or venetoclax (Regimen B) or azacitidine + venetoclax (Regimen C)., Dose Escalation (Regimens A-C): Treatment-emergent adverse events (TEAEs), laboratory test results, physical examination, and vital signs., Dose Expansion Cohorts (Regimens A-C): Composite CR rate (CRMRD-, CR, CRh, CRp, CRi)., Dose Expansion Cohorts (Regimens A-C): Overall response rate (ORR) (CRMRD-, CR, CRh, CRp, CRi, MLFS, PR)., Dose Expansion Cohorts (Regimens A-C): Duration of remission (DOR)., Dose Expansion Cohorts (Regimens A-C): MRD levels using central flow cytometry–based testing., Dose Expansion Cohorts (Regimen D): MRD+ to MRD- conversion rate and relapse-free survival (RFS) in MRD+ Fit (Cohort D1) and MRD+ Unfit (Cohort D2) AML patients., Dose Expansion Cohorts (Regimen D): MRD levels using central flow cytometry–based testing.
Detailed description
Regimens A-C : Treatment-emergent adverse events (TEAEs) (Expansion Cohort)., Regimens A-C: IMGN632 PK parameters for intact antibody-drug conjugate (ADC), total antibody, and free payload (FGN849) include, but are not limited to,Cycle 1 and Cycle 3 maximum plasma concentration (Cmax), area under the time concentration curve (AUC), terminal half-life (t½), clearance (CL), volume of distribution at steady state (Vss), and time that Cmax occurs (tmax)., Regimens A-C: Blood concentration of azacitidine, venetoclax, and azacitidine + venetoclax measured before and after their administration., Regimens A-C: ADA response, Regimens A-C: MRD levels using central flow cytometry–based testing (Dose Escalation Phase)., Regimen D: Treatment-emergent adverse events (TEAEs)., Regimen D: IMGN632 PK parameters for intact ADC, total antibody, and free payload (FGN849) include, but are not limited to, Cycle 1 and Cycle 3 maximum plasma concentration (Cmax), area under the time concentration curve (AUC), terminal half-life (t½), clearance (CL), volume of distribution at steady state (Vss), and time that Cmax occurs (tmax)., Regimen D: ADA response.
Interventions
DRUGVenclyxto 100 mg film-coated tablets
DRUGVidaza 25 mg/ml powder for suspension for injection
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Escalation (Regimens A-C): RP2D of IMGN632 when administered in combination with azacitidine (Regimen A) or venetoclax (Regimen B) or azacitidine + venetoclax (Regimen C)., Dose Escalation (Regimens A-C): Treatment-emergent adverse events (TEAEs), laboratory test results, physical examination, and vital signs., Dose Expansion Cohorts (Regimens A-C): Composite CR rate (CRMRD-, CR, CRh, CRp, CRi)., Dose Expansion Cohorts (Regimens A-C): Overall response rate (ORR) (CRMRD-, CR, CRh, CRp, CRi, MLFS, PR)., Dose Expansion Cohorts (Regimens A-C): Duration of remission (DOR)., Dose Expansion Cohorts (Regimens A-C): MRD levels using central flow cytometry–based testing., Dose Expansion Cohorts (Regimen D): MRD+ to MRD- conversion rate and relapse-free survival (RFS) in MRD+ Fit (Cohort D1) and MRD+ Unfit (Cohort D2) AML patients., Dose Expansion Cohorts (Regimen D): MRD levels using central flow cytometry–based testing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Regimens A-C : Treatment-emergent adverse events (TEAEs) (Expansion Cohort)., Regimens A-C: IMGN632 PK parameters for intact antibody-drug conjugate (ADC), total antibody, and free payload (FGN849) include, but are not limited to,Cycle 1 and Cycle 3 maximum plasma concentration (Cmax), area under the time concentration curve (AUC), terminal half-life (t½), clearance (CL), volume of distribution at steady state (Vss), and time that Cmax occurs (tmax)., Regimens A-C: Blood concentration of azacitidine, venetoclax, and azacitidine + venetoclax measured before and after their administration., Regimens A-C: ADA response, Regimens A-C: MRD levels using central flow cytometry–based testing (Dose Escalation Phase)., Regimen D: Treatment-emergent adverse events (TEAEs)., Regimen D: IMGN632 PK parameters for intact ADC, total antibody, and free payload (FGN849) include, but are not limited to, Cycle 1 and Cycle 3 maximum plasma concentration (Cmax), area under the time concentration curve (AUC), | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed