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

NCT ID: NCT05049668

Last Updated: 2021-09-27

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-31

Study Completion Date

2034-12-31

Brief Summary

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

Detailed Description

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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

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Severe Aplastic Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

Standard treatment with or without Eltrombopag

Interventions

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ATGAM plus CsA with or without Eltrombopag

Standard treatment with or without Eltrombopag

Intervention Type DRUG

Other Intervention Names

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hATG+CsA +/- Revolade

Eligibility Criteria

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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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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European Society for Blood and Marrow Transplantation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Other Identifiers

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EBMT-RACE 2

Identifier Type: -

Identifier Source: org_study_id

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