Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-29 @ 7:25 AM
Study NCT ID:
NCT05049668
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2021-09-27
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RACE 2: a Long Term Follow-up of Patients Participating in the RACE Trial
Sponsor:
European Society for Blood and Marrow Transplantation
Organization:
Study Overview
Official Title:
Long-term Follow-up of Patients Participating in RACE: the Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RACE2
Brief Summary:
After exiting the RACE trial (NCT02099747) patients will be invited to participate in this long term follow-up study
Detailed Description:
Patients will be followed up annually, according to standard of care.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: