Newly diagnosed acute myeloid leukemia. MedDRA version: 17.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Vidaza
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: AZACITIDINE
CAS Number: 320-67-2
Co
Sponsors
Fundación PETHEMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 - Having voluntarily given informed consent before performing any test that is not part of routine care of patients. 2 - Age greater than or equal to 65. 3 - Morphological diagnosis of non-promyelocytic AML according to the WHO criteria. 4 - Newly diagnosed AML. 5 - ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: 1 - Genetic diagnosis of acute promyelocytic leukemia. 2 - Patients with AML secondary to myelodysplastic syndrome (MDS) or chronic myeloproloferative syndrome who have been previously treated with antileukemic agents (hypomethylating or standard chemotherapy). Treatment with hydroxyurea prior to randomization is allowed. 3 - Serum creatinine ? 250 mmol / l ( ? 2.5 mg/dL ) (unless attributed to AML) . 4 - Bilirubin , alkaline phosphatase or ALT > 5 times the value of the upper limit of normal (unless attributed to AML) . 5 - Presence of an active and/or non controlled pathology different to AML which is severe and life-threatening, that in the investigator's opinion, prevents the subject participation in the study . 6 - Other active concomitant malignancy or whose remission is less than one year from the screening day (except carninoma in situ). 7 - Presence of any psychiatric illness or medical condition that , in the investigator's opinion, prevents the subject participation in the study . 8 - Life expectancy less than X months. 9 - Inability of the patient or his legal representative to understand and voluntarily sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the overall survival (OS) in one year treatment with 2 first-line regimens in newly diagnosed elderly patients: 3 cycles of induction chemotherapy based on fludarabine and cytarabine (FLUGA scheme) followed by maintenance with reduced doses (Mini-FLUGA) (standard treatment arm) versus subcutaneous azacitidine cycles (experimental treatment arm).; Secondary Objective: 1.- Evaluate and compare between the two treatment arms the event free survival (EFS), disease-free survival and relapse-free survival at 1st, 2nd and 3rd year, and the cumulative incidence of relapse (CIR). 2.- To assess the duration of remission. 3.- Evaluate overall survival at 2nd and 3rd year. 4- Evaluate the impact in the quality of life in both arms (EQ-5D). 5.- Evaluate the impact of health care resources during the treatment phase 6.- Assess the depth of complete remission (CR) by the percentage of minimal residual disease (MRD) in bone marrow measured by flow cytometry. 7.- To assess the overall response rate after 3 cycles of treatment in both arms. 8.- Evaluate early mortality (first 4 and 8 weeks) in both arms. 9.- Compare hematologic and non-hematologic toxicity in both arms. 10.- Predictors of response. ;Primary end point(s): Overall survival one year from the start of the study treatment.;Timepoint(s) of evaluation of this end point: 1 year after tretament start. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Event-free survival (from the administration of the first dose of treatment) the first, second and third year , defining "event" as relapse or death from any cause. 2. Disease-free survival (from the administration of the first dose of treatment) the first, second and third year. 3. Relapse-free survival for first, second and third year. 4. Duration of remission. 5. Cumulative incidence of relapse. 6. Overall survival at second and third year from the start of treatment. 7. Quality of life of patients assessed by the EQ- 5D questionnaire. 8. Use of antibiotics , transfusions, number and duration of hospitalizations , number of days of attendance at the day hospital. 9. Depth of the RC by the percentage of MRD, performed after three cycles (after the induction phase ) and 9 (after the consolidation phase ) treatment in those patients who achieved CR or CRi . 10. Overall response rate after 3 cycles of treatment in patients initially treated with the experimental therapy ( azacitidine ) compared to patients treated with standard chemotherapy (fludarabine and cytarabine). 11. Early mortality (within 60 days). 12. Haematological and non-haematological toxicity (type, intensity, frequency and severity) according to the Common Terminology Criteria for Adverse Events (CTCAE ) of the National Cancer Institute, version 4.0. Published: May 28 , 2009 (v4.03 : June 14 , 2010). 13. Predictors of response will be sought according to baseline ( Day 1 ) blasts in bone marrow morphology / WHO and FAB classification , WBC, age, sex and other characteristics at diagnosis . ; Timepoint(s) of evaluation of this end point: After cycles 3 and 9 of treatment. At 1st, 2nd and 3rd year after treatment start. | — |
Countries
Spain
Contacts
Public ContactLiana de Plaasencia
Dynamic
Outcome results
None listed