Acute myeloid leukemia (AML) MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Product Name: Vadastuximab talirine
Product Code: SGN-CD33A
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: vadastuximab talirine
CAS Number: 1436390-64
Othe
Sponsors
Seattle Genetics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Inclusion Criteria: • Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo or secondary AML according to WHO classification (except for acute promyelocytic leukemia [APL]) • Intermediate or adverse cytogenetic risk • Eligible for therapy with either decitabine or azacitidine • Acceptable hematologic and organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 518
Exclusion criteria
Exclusion criteria: • AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or t(15;17). • Patients who are candidates for allogeneic stem cell transplant at the time of enrollment • Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis. • Received prior treatment with HMA or chemotherapy for antecedent MDS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To compare the composite complete remission (CRc) rate (morphologic complete remission [CR] and morphologic CR with incomplete hematologic recovery [CRi]) between treatment arms -To compare overall survival (OS) between treatment arms;Secondary Objective: ?To compare the minimal residual disease-negative remission (MRD-negative CRc) rate between treatment arms ?To evaluate the duration of remission in the 2 treatment arms ?To evaluate event-free survival (EFS) in the 2 treatment arms ?To evaluate leukemia-free survival (LFS) in the 2 treatment arms ?To evaluate the safety profiles in the 2 treatment arms ?To evaluate the time to response in the 2 treatment arms ?To evaluate the 30- and 60-day mortality rates in the 2 treatment arms;Primary end point(s): Composite complete remission rate (CRc rate) Overall Survival ;Timepoint(s) of evaluation of this end point: Up to approximately 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?Minimal residual disease (MRD)-negative CRc rate ?Duration of remission ? Event-free survival (EFS) ? Leukemia-free survival (LFS) ? Type, incidence, severity, seriousness, and relatedness of adverse events ? Laboratory abnormalities ? Time to Complete Remission (CR) or Morphologic complete remission with incomplete blood count recovery (CRi) ? Mortality rates at Day 30 and Day 60 post the first study treatment ;Timepoint(s) of evaluation of this end point: • (CR+CRi) CRc rate: Through 1 month following last dose • EFS: Up to approximately 5 years ? Duration of remission: Up to approximately 5 years • LFS: Up to approximately 5 years • Type, incidence, severity, seriousness, and relatedness of adverse events: Through 1 month following last dose • Laboratory abnormalities : Through 1 month following last dose • Time to complete remission : Through 1 month following last dose • Mortality rates at Day 30 and Day 60 post the first study treatment : Day 30 and Day 60 following the first dose • MRD status : Up to approximately 5 years | — |
Countries
Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Luxembourg, Netherlands, Poland, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactLyn McDowell
PRA Health Sciences
Outcome results
None listed