Randomized study with methylprednisolone 1mg/kg/day for treatment of grade I acute GvHD

GITMO GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO,CELLULE STAMINALI EMOPOIETICHE E TERAPIA CELLULARE - ONLUS0 个研究点开始时间: 2012年1月9日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•- 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

•- 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.

发起方

GITMO GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO,CELLULE STAMINALI EMOPOIETICHE E TERAPIA CELLULARE - ONLUS