RACE 2: a Long Term Follow-up of Patients Participating in the RACE Trial (RACE2)

European Society for Blood and Marrow Transplantation

Status: Invitation-only

Conditions: Severe Aplastic Anemia

Treatments: Drug: ATGAM plus CsA with or without Eltrombopag

Study type: Observational

Funder types: NETWORK

Identifiers

NCT05049668

EBMT-RACE 2

Details and patient eligibility

About

After exiting the RACE trial (NCT02099747) patients will be invited to participate in this long term follow-up study

Full 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.

Enrollment: 197 estimated patients

Sex

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject participated in the RACE trial (NCT02099747, EudraCT number: 2014-000363-40) during which patient received ATGAM, Cyclosporine A with or without Eltrombopag.
2. Subject has provided informed consent to participate in long-term data collection

Exclusion criteria

None

Trial design

197 participants in 1 patient group

RACE 1 patients

Description:

After exiting the RACE trial (NCT02099747) patient will be invited to participate in this study

Treatment:

Drug: ATGAM plus CsA with or without Eltrombopag