A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant

Jazz Pharmaceuticals Inc.0 个研究点目标入组 152 人开始时间: 2019年5月16日最近更新: 2021年12月21日

试验速览

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•1. Patient must be =1 year of age at screening and undergoing allogeneic HSCT.
•2. Patient must be diagnosed with acute leukemia in morphologic complete remission (CR1 or CR2) or with MDS with no circulating blasts and with less than 5% blasts in the bone marrow
•3. Patient must have planned to receive either a myeloablative or reducedintensity conditioning regimen and have an unrelated donor who
•is HLA matched or single-allele mismatched
•4. Graft must be a CD3+ T-cell replete PBSC graft or non-manipulated BM graft.
•5. Adult patients must be able to understand and sign a written informed consent. For pediatric patients, the parent/legal guardian or representative must be able to understand and sign a written informed consent. Assent, when appropriate, will be obtained according to
•institutional guidelines.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 112
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•1. Patient has had a prior autologous or allogeneic HSCT.
•2. Patient is using or plans to use an investigational agent for the prevention of GvHD.
•3. Patient is receiving or plans to receive other investigational therapy
•4. Patient, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
•5. Patient has a psychiatric illness that would prevent the patient or legal guardian or representative from giving informed consent and/or
•6. Patient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of
•this study.
•7. Patient is pregnant or lactating and does not agree to stop
•breastfeeding.
•8. Any other condition that would cause a risk to the patient if he/she participated in the trial.
•9. Patient has a known history of hypersensitivity to defibrotide or any of its excipients. Patient has a known hypersensitivity to any agent(s) or excipients of agent(s) within patient’s planned immunoprophylaxis regimen.

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