Study of Fludarabine based conditioning for Allogeneic Stem cell Transplantation for Myelofibrosis - ND

Conditions: MYELOFIBROSIS
MedDRA version: 9.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disorders

Registration Number: EUCTR2007-001413-42-IT

Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 64

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 4. life exoectancy > 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

1. PREGNANCY

2.HIV POSITIVE

3. >20% MYELOBLASTS IN THE PERIPHERAL BLOOD OR BONE MARROW

4.LVEF<45%

5. DLCO< 60% OF PREDICTED

6. COG PERFORMANCE STATUS >= 3

7. CHRONIC ACTIVE HEPATITIS OR CIRRHOSIS

8. CHRONIC RENAL INSUFFICENCY

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures