MYELOFIBROSIS MedDRA version: 9.1 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: FLUDARA
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Fludarabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
AZIENDA OSPEDALIERA "OSPEDALI RIUNITI DI BERGAMO" (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.patients with the following disease. idiophatic myelofibrosis, or spent PV-, or ET-related myelofibrosis in chronic phase (20% blast cells in the bone morrow); 2.age 18-65 years 3.ECOG performance status 3 months; 5.Adequate cardiac function(FEV ≥45%)and pulmonary (DLCO ≥60%), Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. PREGNANCY 2.HIV POSITIVE 3. >20% MYELOBLASTS IN THE PERIPHERAL BLOOD OR BONE MARROW 4.LVEF= 3 7. CHRONIC ACTIVE HEPATITIS OR CIRRHOSIS 8. CHRONIC RENAL INSUFFICENCY
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): ;Main Objective: ESTIMATE PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL OF PATIENTS WITH MYELOFOBROSIS UNFi'DERGOING AND ALLOGENEIC hsc TRANSPLANT PREPARED WITH A REDICED INTENSITY CONDITIONIG REGIMEN;Secondary Objective: 1. To estimate the clinical and histological response of the a patients with risk idiophatic; 2. To estimate the rate of engraftment for patients with poor risk idiophatic 3. To estimate the morbidity and mortality for patients with poor risk idiophatic 4. To estimate the role of the biomarkers after the transplant. | — |
Countries
Italy
Outcome results
None listed