elderly patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome MedDRA version: 9.1 Level: HLT Classification code 10024291 Term: Leukaemias acute myeloid
Conditions
Interventions
Trade Name: FLUDARA
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Fludarabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Tra
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with de novo or secondary acute myeloid leukemia or with Int 2 or High risk myelodysplastic syndrome, according to IPSS. 2. Patients unable or unfit to receive an hematopoietic stem cell transplantation from an HLA-identical related or unrelated, or HLA-haploidentical related donor. 3. Hematologic complete remission after 1 or 2 cycles of induction standard chemotherapy. 4. Successful collection of autologous peripheral blood hematopoietic stem cells: ≥ 5.0x10e6 /kg patient BW. 5. Age ≥ 65 years. 6. Performance Status 0-2 ECOG, 60-100% Karnofsky. 7. Written informed consent. 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. Diagnosis of AML M3. 2. Second concomitant malignancies 3. Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function) 4. Known and manifested malignant involvement of the CNS 5. Active infectious disease 6. HIV- positivity or active hepatitis infection 7. Impaired liver function (bilirubin > 1.5 x upper normal limit; transaminases > 3.0 x upper normal limit) 8. Impaired renal function (creatinine-clearance 1.5 x upper normal limit). 9. Pleural effusion or ascites > 1.0 L 10. Known hypersensitivity to treosulfan and/or cytarabine and/or fludarabine 11. Participation in another experimental drug trial within 4 weeks before day -6 12. Non-cooperative behaviour or non-compliance 13. Psychiatric diseases or conditions that might impair the ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Evaluation of disease free survival;Secondary Objective: -Evaluation of engraftment of autotransplant -Evaluation of incidence of CTC grade 3 and 4 adverse events within day +90 -Evaluation of non-relapse mortality within day +90 -Evaluation of non-relapse mortality at +1 year and + 2 years -Evaluation of overall survival -Evaluation of relapse incidence;Primary end point(s): Disease-free survival (DFS) | — |
Countries
Italy
Outcome results
None listed