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NCT04436380 · ClinicalTrials.gov registry record
Retrospective Study of Patients With Severe Aplastic Anemia Who Relapsed After Immunosuppressive Therapy
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 173
- Enrollment target
NCT04436380: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT04436380 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 173 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04436380 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 173 participants
- Enrollment target
Study Summary
Background: Severe aplastic anemia (SAA) is a form of bone marrow failure. It usually results from a cytotoxic T cell attack on the marrow stem cell. Two treatments can be used for most people with SAA. One is allogeneic hematopoietic stem cell transplant (HSCT). The other is immunosuppressive treatment (IST). For people who are treated with IST, relapse can occur. If this happens, they can have HSCT or be re-treated with IST. The two most common IST regimes used for relapsed SAA are rabbit ATG (rATG) and alemtuzumab. Both rATG and alemtuzumab have similar response rates and survival rates. There is not much long-term data on people who need repeat IST treatment due to relapse. Researchers want to look at data from past studies to learn more. Objective: To compare the data of relapsed SAA patients between those who received alemtuzumab versus rATG for repeat IST treatment. Eligibility: Adults and children with SAA who were enrolled on NHLBI protocol 12-H-0150, 06-H-0034, 05-H-0242, 03-H-0249, 03-H-0193, 00-H-0032, or 90-H-0146 Design: This study uses data from past studies. The participants in those studies have allowed their data to be used in future research. Researchers will review participants medical records. They will collect clinical data, such as notes, test results, and imaging scans. They will also collect the research data gathered as part of the original study. Researchers will enter the data into an in-house database. It is password protected. All data will be kept in secure network drives or in secure sites. Other studies may be added in the future....
Primary Outcome
Characteristics and outcomes of relapsed SAA patients between those who received alemtuzumab versus rATG for repeat IST
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2020-06-15 |
| Est. Completion | 2023-03-15 |
What the finished NCT04436380 record still lists
NCT04436380 is an observational study that tracks outcomes without assigning an intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04436380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04436380 about?
NCT04436380 is a clinical study titled "Retrospective Study of Patients With Severe Aplastic Anemia Who Relapsed After Immunosuppressive Therapy". Background: Severe aplastic anemia (SAA) is a form of bone marrow failure. It usually results from a cytotoxic T cell attack on the marrow stem cell. Two treatments can be used for most people with SAA. One is allogeneic hematopoietic stem cell transplant (HSCT). The other is immunosuppressive tre...
What is the current status of trial NCT04436380?
This trial is currently completed. The enrollment target is 173 participants. The study started on 2020-06-15. Estimated completion is 2023-03-15.
Who is sponsoring clinical trial NCT04436380?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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