patients with acute GVHD not responsive MedDRA version: 9.1 Level: LLT Classification code 10018651 Term: Graft versus host disease
Conditions
Interventions
Product Code: bt 5/9
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: anti-CD26
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: equal
Concentration number:
Sponsors
FONDAZIONE RICERCA TRAPIANTO DI MIDOLLO OSSEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Feasibility of treatment Efficacy Safety;Secondary Objective: none;Primary end point(s): Responsive patients to study treatment | — |
Countries
Italy
Outcome results
None listed