RACE 2: a Long Term Follow-up of Patients Participating in the RACE Trial
NCT ID: NCT05049668
Last Updated: 2021-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
197 participants
OBSERVATIONAL
2021-10-31
2034-12-31
Brief Summary
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Detailed Description
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All diagnostic and therapeutic intervention will be performed according to standard of care, at discretion of the treating physician. In particular, during the study no extra Peripheral blood or Bone Marrow sampling will be performed, in addition to routine sampling for morphology and karyotype surveillance.
Molecular analysis by Next Generation Sequencing (NGS) will also be collected if the centre is doing this on a routine basis.
No Investigational Medicinal Product (IMP) or Non-Investigational Medicinal Product (NIMP) will be given to the patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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RACE 1 patients
After exiting the RACE trial (NCT02099747) patient will be invited to participate in this study
ATGAM plus CsA with or without Eltrombopag
Standard treatment with or without Eltrombopag
Interventions
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ATGAM plus CsA with or without Eltrombopag
Standard treatment with or without Eltrombopag
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject has provided informed consent to participate in long-term data collection
Exclusion Criteria
No
Sponsors
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European Society for Blood and Marrow Transplantation
NETWORK
Responsible Party
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Principal Investigators
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Regis Peffault de Latour, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital St. Louis, Paris, France
Antonio M Risitano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Avellino, Napels, Italy
Locations
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Hospital St. Louis
Paris, , France
Countries
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Other Identifiers
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EBMT-RACE 2
Identifier Type: -
Identifier Source: org_study_id
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