evaluation of toxicity and efficacy of a transplantation program with high dose cyclophosphamide post transplant as GVHD prophylaxis in patients who underwent to allo transplant after RIC.

• Conditions: Elderly patients (66-70 years) with acute leukemia or high-risk MDS who, underwent allogenic transplant of peripheral hematopoietic progenitors after reduced-intensity conditioning.; MedDRA version: 15.1Level: LLTClassification code 10018653Term: Graft-versus-host disease <GVHD>System Organ Class: 100000004870; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-004118-33-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-19
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is the NRM to 90 days after allogenic transplant peripheral blood stem cells after reduced-intensity conditioning in a population of elderly patients (66-70 years) with LA / high-risk MDS.;Secondary Objective: Secondary objectives are evaluation engraftment, chimerism, incidence of acute and chronic GVHD, DFS, OS and NRM at one year post-transplant.;Primary end point(s): Mortality not related to recurrence disease in the first 90 days.;Timepoint(s) of evaluation of this end point: 90 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary objectives are evaluation rate of engraftment, full chimerism, incidence of acute and chronic GVHD, DFS, OS and NRM at one year post-transplant.;Timepoint(s) of evaluation of this end point: NA