Acute Myloid Leukemia MedDRA version: 9.1 Level: LLT Classification code 10000880 Term: Acute myeloid leukaemia MedDRA version: 9.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia
Conditions
Interventions
Product Name: Decitabine
Product Code: Decitabine
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Decitabine
CAS Number: 2353335
Current Sponsor code: D-150
Other descripti
Sponsors
Eisai Medical Research Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be included in the study only if they meet all of the following criteria: 1. Must sign an institutional review board/ethics committee-approved informed consent. 2. Must have a newly diagnosed, histologically confirmed de novo or secondary AML using the World Health Organization classification (e.g., =20% blasts). 3. Must be at least 65 years of age and have either poor- or intermediate-risk cytogenetics as categorized by Southwest Oncology Group. 4. Must have a performance status of 0-2 on the Eastern Cooperative Oncology Group scale (see protocol appendix 1) 5. Must have adequate organ function, defined as: - Hematology: WBC = 40,000/mm; - Hepatic: Bilirubin less than or equal to 1.5 times the upper limit of normal, AST or ALT less than or equal 2.5 times the upper limit of normal; and - Renal: Creatinine clearance (calculated by the Cockroft and Gault method) greater than or equal to 40 mL/min; 6. Must have a life expectancy of at least 12 weeks. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Must not have acute promyelocytic leukemia (M3 classification). 2. Must not have t(8;21), inv(16) or t(15;17) karyotype abnormalities. 3. Must not have known CNS leukemia. 4. Must not have any other active systemic malignancies. 5. Must not have unstable angina or New York Heart Association (NYHA) class 3 or 4 congestive heart failure (see protocol appendix 3). 6. Must not have inaspirable bone marrow. 7. Must not have received previous chemotherapy (except hydroxyurea), including azacytidine (Vidaza), cytarabine or decitabine, for any myeloid disorder. 8. Must not have chronic respiratory disease that requires continuous oxygen use. 9. Must not have received any experimental drug within 4 weeks of randomization. 10. Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization. 11. Must not have any concomitant medical or psychiatric disorders incompatible with the study (at the discretion of the investigator). 12. Must not have any comorbidity that causes organ dysfunction that is not related to leukemia. 13. Must not have an uncontrolled active infection(s) requiring IV antibiotics. 14. Must not have known HIV. 15. Must not have had radiotherapy for extramedullary disease within 2 weeks prior to study randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the overall survival in patients 65 years and older who have newly diagnosed de novo or secondary Acute Myloid Leukemia and either poor or intermediate risk cytogenetics who are randomly assigned to receive either decitabine or patients choice with physicians advice of either supportive care or low dose cytarabine.;Secondary Objective: To compare complete remission rates between treatment arms. To characterize and compare the incidence and severity of toxicities in the two treatment arms.;Primary end point(s): Patients may remain on study treatment until one of the following occurs: • death; • for patients receiving decitabine or cytarabine, relapse or disease progression (see protocol section 3.5.5.); • for patients receiving decitabine or cytarabine, no longer deriving clinical benefit from therapy; • unacceptable toxicity; • intercurrent illness that prevents further administration of treatment; • patient/physician request; or, • general or specific changes in the patient’s condition that renders the patient unacceptable for further treatment in the judgment of the investigator. | — |
Countries
Czech Republic, Hungary, Spain
Outcome results
None listed