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NCT05502783 · ClinicalTrials.gov registry record · Phase 2
Using Fostamatinib to Treat Post-Hematopoietic Stem Cell Transplant Immune-mediated Cytopenias
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT05502783: Clinical Trial Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT05502783 is a Phase 2 study that was terminated before completion, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05502783, a Phase 2 study, was terminated before completion, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Background: People who have a blood stem cell transplant can sometimes develop cytopenia. This means that their levels of one or more types of blood cell, such as the red cells or platelets, are lower than they should be. This can occur because a person s immune system might attack these cells after a stem cell transplant. Cytopenia can lead to anemia, severe bleeding, infections, and other problems. Treatments are needed to help keep blood cell levels stable after blood stem cell transplant. Objective: To test a study drug (fostamatinib) in people who have cytopenia after a blood stem cell transplant. Eligibility: People aged 18 to 75 years who have cytopenia after a blood stem cell transplant. Design: Participants will be screened. They will have a physical exam. They will have blood, urine, and stool tests. Fostamatinib is an oral tablet taken by mouth. Participants will take the pills 2 times a day for 12 weeks. Participants will have a medical assessment every 2 weeks; their vital signs will be checked, and they will have blood and stool tests. Participants must come to the NIH clinic for these visits in weeks 4 and 12. Other visits may be done by telephone or telehealth; the blood and stool tests can be sent to the researchers from a local lab. After 4 weeks, some participants may begin taking a higher dose of the drug. Participants will return for a final medical assessment 2 weeks after they finish taking the drug. Participants who complete this study and show evidence that fostamatinib has increased their blood cell counts may enroll in an extension study to continue taking fostamatinib.
Primary Outcome
Stable hematologic recovery (improvement documented in 2 consecutive available readings) without recent blood product transfusion support (in the past 48-72 hours). Hematologic recovery is defined as: * Hemoglobin =10 g/dL (or at least =2 g/dL above baseline) in participants enrolled with posttransplant anemia. In participants with symptomatic anemia, a hemoglobin increase of at least =2 g/dL above baseline is required OR * Platelets = 50 x 10\^9/L (or at least =20 x 10\^9/L above baseline) in
Interventions
- DRUG fostamatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-03-10 |
| Est. Completion | 2023-06-16 |
| Phase | Phase 2 |
Why NCT05502783 stopped before completion
NCT05502783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which fostamatinib is the first listed.
NCT05502783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05502783 about?
NCT05502783 is a clinical study titled "Using Fostamatinib to Treat Post-Hematopoietic Stem Cell Transplant Immune-mediated Cytopenias". Background: People who have a blood stem cell transplant can sometimes develop cytopenia. This means that their levels of one or more types of blood cell, such as the red cells or platelets, are lower than they should be. This can occur because a person s immune system might attack these cells afte...
What is the current status of trial NCT05502783?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2023-03-10. Estimated completion is 2023-06-16.
What interventions are being tested in trial NCT05502783?
The interventions under investigation include: fostamatinib (DRUG).
Who is sponsoring clinical trial NCT05502783?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05502783's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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