EUCTR2006-004420-37-GB进行中（未招募）1 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must be 6 months to 70 years of age, inclusive
- •Subjects who have failed to respond to steroid treatment:
- •Failure to respond to steroid treatment is defined as any Grade B-D (IBMTR grading) of acute GVHD that shows:
- •- No improvement after 3 days and
- •- A duration of no greater than 2 weeks
- •while receiving treatment with Methylprednisolone (= 1 mg/kg/day) or equivalent.
- •Subjects must be able to be treated within 4 days of randomization. In urgent situations 2nd line therapy may be started 24 hours prior to randomization, and Prochymal must be initiated within the following 3 days.
- •Subjects with persistent GI GVHD manifested by diarrhea with stool volume < 500
- •mL/day in the absence of nausea or vomiting may be deemed as having grade B GVHD if other causes of diarrhea have been ruled out (e.g., C. difficile or CMV infection, oral magnesium administration) and if the low stool volume reflects the effects of fasting or administration of narcotics or anti-diarrheal medications.
- •Subjects who may have received an increase in their steroid dose treatment prior to randomization will be eligible for enrollment. An increase in steroid dose will not be
- •considered as second line therapy.
- •Subjects must have adequate renal function as defined by:
- •For adult patients: Calculated Creatinine Clearance of >30mL/min using the Cockroft-Gault equation
- •For pediatric patients: Schwartz equation (Patient population: infants over 1 week old through adolescence (<18 years old)
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject has started treatment with second line therapy > 24 hours prior to randomization.
- •Subject has received agents other than steroids for primary treatment of acute GVHD
- •Subject has evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and is likely to require more than 2L of oxygen via face mask or an estimated FiO2 of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.
- •Subject is participating in the CTN Protocol 0302
- •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 for any indication) 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.
研究者
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