A clinical study to investigate 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

Phase 1

• Conditions: Prevention of Acute Graft-versus-Host Disease (aGvHD) after allogeneic hematopoietic stem cell transplant; MedDRA version: 20.0Level: LLTClassification code 10068908Term: AGVHDSystem Organ Class: 100000004870; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2017-003309-16-GR
• Lead Sponsor: Jazz Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-03
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

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
assent.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified