Treatment of Steroid refractory Graft versus Host Disease with monoclonal antibody B T 5/9 (anti-CD26) - ADN-GVHD vs BT 5/9
- Conditions
- patients with acute GVHD not responsiveMedDRA version: 9.1Level: LLTClassification code 10018651Term: Graft versus host disease
- Registration Number
- EUCTR2007-005809-21-IT
- Lead Sponsor
- FONDAZIONE RICERCA TRAPIANTO DI MIDOLLO OSSEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
a)18 - 65 years
b)Signed informed consent must be obtained prior to conducting any study procedure
c)Acute GvHD II-IV grade
d)patients who underwent HSCT without distinction of donor type and/or of donor leukocyte infusions (DLI)
e)standard prophylaxis prior to transplantation
f)cyclosporine with methotrexate for GVHD prophylaxis after transplantation
g)Staging and grading of acute GVHD were according to the Glucksberg criteria
h)Acute GvHD II-IV grade not responding to 5 days of steroids
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
a)Life expectation < 10 day
b)Patients with Chronic GVHD
c)HIV+, HBsAg+ or HCV+
d)Multi-organ system failure
e)Subjects who developed a lymphoproliferative disorder after HSCT
f)pregnant and/or lactating
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Feasibility of treatment<br>Efficacy<br>Safety;Secondary Objective: none;Primary end point(s): Responsive patients to study treatment
- Secondary Outcome Measures
Name Time Method