RACE 2: a Long Term Follow-up of Patients Participating in the RACE Trial
RACE2
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
1 other identifier
observational
197
1 country
1
Brief Summary
After exiting the RACE trial (NCT02099747) patients will be invited to participate in this long term follow-up study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
September 20, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2034
September 27, 2021
September 1, 2021
12.2 years
September 13, 2021
September 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Failure Free Survival
Failure Free Survival, where treatment failure is defined as one or more of the following: death, relapse, malignant clonal evolution, need for further (e.g. transplant)
15 years
Secondary Outcomes (12)
Response Rate: number of patients who reach a hematological response
15 years
Overall Survival
15 years
Cumulative incidence of relapse after response
15 years
Cumulative incidence of clonal evolution
15 years
Cumulative incidence of clinical Paroxysmal nocturnal hemoglobinuria (PNH)
15 years
- +7 more secondary outcomes
Study Arms (1)
RACE 1 patients
After exiting the RACE trial (NCT02099747) patient will be invited to participate in this study
Interventions
Standard treatment with or without Eltrombopag
Eligibility Criteria
Patients who participated in the initial RACE 1 trial
You may qualify if:
- Subject participated in the RACE trial (NCT02099747, EudraCT number: 2014-000363-40) during which patient received ATGAM, Cyclosporine A with or without Eltrombopag.
- Subject has provided informed consent to participate in long-term data collection
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital St. Louis
Paris, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Regis Peffault de Latour, Prof, MD
Hospital St. Louis, Paris, France
- PRINCIPAL INVESTIGATOR
Antonio M Risitano, MD, PhD
Hospital Avellino, Napels, Italy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 15 Years
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2021
First Posted
September 20, 2021
Study Start
October 1, 2021
Primary Completion (Estimated)
December 1, 2033
Study Completion (Estimated)
December 1, 2034
Last Updated
September 27, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share