A multicenter phase II trial of Recipient pre-treatment with Short-Term Rapamycin for the prevention of acute GVHD after hematopoietic stem cell transplantation in Elderly Patients - ND

• Conditions: Graft Versus Host Disease; MedDRA version: 9.1Level: LLTClassification code 10048396Term: Bone marrow transplant rejection; MedDRA version: 9.1Level: LLTClassification code 10000802Term: Acute GVH disease

• Registration Number: EUCTR2008-002310-22-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-25
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

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

Inclusion Criteria

Signed informed consent
Age > 55 years
Bone Marrow or PBSC graft
HLA-identical or 1 antigen-mismatched donor
Early disease (non neoplastic disease, AML or ALL in 1st complete remission, CML in 1st chronic phase, chemosensitive Lymphoma or Myeloma)
Reduced Intensity Conditioning (RIC) regimen
Normal renal or hepatic function
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unable to sign informed consent
Age <50 years
Cord Blood grafts
>1 HLA antigen mismatched donor
Advanced disease (based on above definitions of early disease)
Myeloablative conditioning
Renal failure (creatinine > 2 mg/dL or creatinine clearance <60 ml/24 hrs)
Altered hepatic function (AT > 5 times normal or bilirubin > 3 mg/dL)
HBV, HCV or HIV infection

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Te evaluate the incidence of acute GVHD grade II-IV.;Secondary Objective: To evaluate: <br>time to acute GVHD grade II-IV <br>incidence of acute GVHD any grade<br>time to acute GVHD any grade<br>overall survival,<br>relapse rate<br>incidence of chronic GVHD<br>time to chronic GVHD<br>Biological end points include the monitoring of the phenotype and function of peripheral blood lymphocytes and APC.;Primary end point(s): Te evaluate the incidence of acute GVHD grade II-IV.