EUCTR2012-004118-33-ITActive, not recruitingNot Applicable
High-dose cyclophosphamide role in the prophylaxis of GVHD in elderly patients (66-70 years) with acute leukemia or myelodysplasia high-risk, submitted to allogenic transplant of peripheral hematopoietic progenitor cells after reduced-intensity conditioning. - transplant over66
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)0 sitesStarted: December 19, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •LAM high risk [intermediate or poor risk cytogenetics - normal karyotype with unfavorable molecular alterations - failure of the 1st cycle of induction - secondary leukemia - second complete remission] in complete remission High-risk MDS (IPSS = intermediate II) ALL in complete remission Age> 66 years and <71 Availability of an HLA-matched donor hematopoietic progenitors Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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 20
Exclusion Criteria
- •Age> 70 years Psychiatric disorders or other conditions that compromise adequate compliance to the therapeutic program Karnofsky score <60% EF <40% Renal disease (creatinine clearance <40 ml / min) Severe liver disease (ALT> 2.5 vv normal value) or acute hepatitis Deficits in lung function (FEV1, FVC, DLCO <50% of the expected after correction for hemoglobin) HIV (Human Immunodeficiency Virus) HIV Obesity morbigena, or third-degree Infections in the active phase A history of cancer of other organs and tissues not in remission or at high risk of recurrence if prolonged immunosuppressive therapy.
Investigators
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