acute myelogenous leukemia cancer of the blood
Conditions
Interventions
Both Arms
HMA, either:
* Azacitidine 75 mg/m2 given subcutaneously (SC) or intravenously (IV) x 7 (7
consecutive days or 5 days on/2 days off/2 days on), every 4 weeks, or
* Decitabine 20 mg/m2 given
combination with
newly diagnosed acute myeloid leukemia (AML)
talirine
vadastuximab
Sponsors
Seattle Genetics, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed, previously untreated, cytologically or histologically confirmed de novo or secondary AML according to WHO classification (except for acute promyelocytic leukemia [APL]). 2. Age >=18 years. 3. Life expectancy of at least 12 weeks. 4. Patient is eligible for therapy with either decitabine or azacitidine. 5. For patients =80 years must be have an ECOG performance status of 0 or 1. 6. The following baseline laboratory data: * White blood cell (WBC) count =30 mL/min. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Exclusion criteria
Exclusion criteria: 1. AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or t(15;17). 2. Patients who are medically fit and willing to receive standard intensive induction chemotherapy. 3. Patients who are candidates for allogeneic stem cell transplant at the time of enrollment. 4. Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis. 5. Received prior treatment with HMA or chemotherapy for antecedent MDS. Prior hydroxyurea or 6-mercaptopurine is permitted, as is prior lenalidomide treatment for MDS. 6. History of allogeneic stem cell transplant. 7. History of clinically significant chronic liver disease (e.g. liver cirrhosis) and/or ongoing alcohol abuse. 8. Patient with supplemental oxygen requirement or resting oxygen saturation of 1 year from enrollment (except for hormonal/anti hormonal treatment, e.g., breast cancer). 10. Central nervous system leukemia based on imaging or documented positive cytology in cerebral spinal fluid. 11. Any uncontrolled Grade 3 or higher (per NCI CTCAE, Version 4.03) viral, bacterial, or fungal infection within 14 days prior to the first dose of study treatment. Antimicrobial prophylaxis or ongoing treatment of resolving/controlled infection is permitted. 12. Patients with any of the following: * Known positive hepatitis B polymerase chain reaction (PCR) assay who have also tested positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody; patients with a negative PCR assay are permitted with appropriate antiviral prophylaxis. * Known or suspected active hepatitis C infection (positive by PCR or on antiviral therapy within the last 6 months). * Known human immunodeficiency virus (HIV) infection. 13. Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, or myocardial infarction within 6 months prior to their first dose of study drug, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to the first dose of study treatment (see Appendix F). 14. Current therapy with other systemic anti-neoplastic or investigational agents, with the exception of hydroxyurea. 15. Females who are breastfeeding. 16. Known hypersensitivity to any excipient contained in the drug formulation of any study treatment. 17. Significant history of pulmonary, renal, neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic, cardiovascular disease, or any other condition which, in the opinion of the investigator, would adversely affect participation in this study, compromise patient safety or interfere with data interpretation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint of this study is CRc rate OS. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: * MRD-negative CRc rate *Duration of remission * EFS * LFS * Type, incidence, severity, seriousness, and relatedness of adverse events * Laboratory abnormalities * Time to CR or CRi * Mortality rates at Day 30 and Day 60 post the first study treatment | — |
Countries
Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Korea (the Republic of), Luxembourg, Netherlands, Norway, Poland, Spain, Sweden, Taiwan (Province of China), United Kingdom, United States of America
Outcome results
None listed