Acute myeloid leukaemia MedDRA version: 14.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: HYDROXYCARBAMIDE
CAS Number: 127-07-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: NA-
Pharmaceutical Fo
Sponsors
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed written informed consent according to ICH/EU/GCP and national/local laws - Patients aged between 18 and 60 years - Patients previously untreated for their AML by other chemotherapeutic agents (with the exception of no more than 7 days HU), radiotherapy or more than 7 days corticosteroids - Unequivocal diagnosis of untreated de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), with FAB classification other than M3 (acute promyelocytic leukemia), documented by bone marrow aspiration (or biopsy in case of dry tap) (not supervening after other myeloproliferative disease or myelodysplastic syndromes of more than 6 months duration) - WHO performance status 0-3 - Adequate renal (serum creatinine 50%, as determined by echocardiogram - Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection - Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 237 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients aged less than 18 or more than 60 years - Patients already treated for their AML by other chemotherapeutic agents (with the exception of no more than 7 days HU), radiotherapy or more than 7 days corticosteroids - Acute promyelocytic leukaemia - Blast crisis of chronic myeloid leukaemia - AML supervening after other myeloproliferative disease - AML supervening after antecedent myelodysplastic syndromes of more than 6 months duration - Other progressive malignant diseases. However, secondary AML following previously cured malignancies may be included as well as secondary AML following previous exposure to alkylating agents or radiation for other reason - Inadequate renal or liver function (metabolic abnormalities > 3 times the normal upper limit) - Severe heart failure requiring diuretics - Ejection fraction < 50% - Uncontrolled infections - WHO performance status = 4 - Severe concomitant neurological or psychiatric diseases - Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of Dasatinib. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to evaluate the treatment strategy in terms of Overall Survival (OS) at 24 months;Secondary Objective: - Disease Free Survival (DFS) - Event Free Survival (EFS) - Cumulative incidence of relapse (CIR) - Response rate after induction therapy - Safety: adverse events (AE) and serious AE (SAE) - OS, EFS, DFS and CIR in different risk groups - OS, EFS, DFS and CIR according to the MRD level - Response rate, OS, EFS, DFS and CIR according to baseline characteristics such as age, performance status, white blood cell (WBC), morphology, cytogenetic and molecular features. - Quality of Life evaluation;Primary end point(s): To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study end-points are: 1. Estimation of Disease Free Survival (DFS) from CR evaluation. 2. Estimation of Event Free Survival (EFS) from study entry. 3. Estimation of Cumulative incidence of relapse (CIR) from CR evaluation. 4. Rate of patients in CR after induction therapy 5. Toxicity according to CTCAE version 4.0 6. Estimation of OS, EFS, DFS and CIR according to risk groups (Low, Intermediate, High) 7. Estimation of OS, EFS, DFS and CIR according to the MRD level at each evaluation step 8. Rate of CR patients and estimation OS, EFS, DFS and CIR according to baseline characteristics such as age, performance status, white blood cell (WBC), morphology, cytogenetic and molecular features. 9. Quality of Life evaluation;Timepoint(s) of evaluation of this end point: During and at the end of the treatment | — |
Countries
Italy
Contacts
Public ContactCentro Dati
GIMEMA
Outcome results
None listed