NCT05049668

RACE 2: a Long Term Follow-up of Patients Participating in the RACE Trial

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
• Phase: —
• Study type: Observational
• Enrollment: 197 (estimated)
• Sponsor: European Society for Blood and Marrow Transplantation · Network
• Sex: —
• Age: —
• Healthy volunteers: —

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.

Conditions

• Severe Aplastic Anemia

Interventions

Type	Name	Description
DRUG	ATGAM plus CsA with or without Eltrombopag	Standard treatment with or without Eltrombopag

Timeline

• Start date: 2021-10-01
• Primary completion: 2033-12-01
• Completion: 2034-12-01
• First posted: 2021-09-20
• Last updated: 2021-09-27

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study