Subjects must have steroid refractory treatment of Grades B-D acute GVHD secondary to allogeneic HSCT (stem cells sources: bone marrow, peripheral blood stem cells, or cord blood cells) or DLI. MedDRA version: 9.1 Level: LLT Classification code 10018651 Term: Graft versus host disease
Conditions
Interventions
Trade Name: Prochymal
Pharmaceutical Form: Solution for infusion
Other descriptive name: Prochymal = Cellule Staminali Mesenchimali in coltura Ex-vivo da Donatori Umani Adulti
Concentration unit: IU i
Sponsors
OSIRIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must be 6 months to 60 years of age, inclusive ? Subjects who were diagnosed with steroid refractory Grades B-D acute GVHD post HSCT or post DLI ? Subjects must be able to be treated within 3 days (+ 1) of diagnosis of steroid-refractory acute GVHD ? Subjects must have adequate renal function as defined by: Calculated Creatinine Clearance of >30mL/min using the Cockroft-Gault equation ? Subjects who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male subjects must use adequate contraception ? Subject must have a minimum Karnofsky/Lansky Performance Level of at least 30 at the time of study entry ? Subject (or legal representative where appropriate) must be capable of providing written informed consent. Are the trial subjects under 18? yes 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: Subject has started treatment with second line therapy prior to randomization. ? Subject has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject including uncontrolled infection, heart failure, pulmonary hypertension, etc. ? Subjects may not receive any other investigational agents (not approved by the FDA) concurrently during study participation or within 30 days of randomization. ? Subject has a known allergy to bovine or porcine products. ? Subject has received a transplant for a solid tumor disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To gather additional information on the safety of Prochymal in subjects experiencing steroid-refractory Grades B-D acute GVHD.;Primary end point(s): Complete Response of major or equal to 28 days duration;Main Objective: To evaluate the efficacy of Prochymal in subjects experiencing steroidrefractory Grades B-D acute GVHD | — |
Countries
Italy, Spain, United Kingdom
Outcome results
None listed