patients developing acute GvHD grade I MedDRA version: 14.1 Level: LLT Classification code 10000802 Term: Acute GVH disease System Organ Class: 100000004870
Conditions
Interventions
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Methylprednisolone and antiinfectives
Sponsors
GITMO GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO,CELLULE STAMINALI EMOPOIETICHE E TERAPIA CELLULARE - ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Prior allo-SCT using either BM, PB or cord blood from related or unrelated donors. - Patients developing aGvHD after prophylactic or planned donor lymphocyte infusion (DLI) are also eligible. - Signed informed consent - Skin rash on 10-50% of body surface compatible with aGvHD and not directly attributable to other etiologies. Biopsy confirmation of aGVHD is strongly encouraged but not mandatory and in any case should not delay enrollment (see Appendix). - Patients must not have previous systemic corticosteroid therapy higher than 0,5 mg/kg/day MP (0.6 mg/kg/day prednisone) within 48 hours prior aGVHD onset. Are the trial subjects under 18? yes Number of subjects for this age range: 0 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
Exclusion criteria: - Any life-threatening infection or condition. - Evidence of hematological relapse or residual disease at the time of enrollment. - Patients who have undergone unscheduled DLI for relapse. - Other investigational immunosuppressive regimens for GvHD prophylaxis within 30 days. - Patients receiving MP >0.5 mg/kg/day within 2 days of onset of aGVHD. - Patients receiving steroids for a non-GvHD related condition are eligible only after tapering to ≤0.5 mg/kg/day for at least 48 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): - Progression rate to acute GVHD grade > 1 in the two study arms.;Main Objective: To determine if methylprednisolone 1 mg/kg/day at the onset of grade I acute GvHD may reduce the progression rate to acute GVHD grade > 1 in patients who have undergone allogeneic SCT.;Secondary Objective: N.A. | — |
Countries
Italy
Outcome results
None listed