Study withdrawn: extended access to fostamatinib for transplant patients never launched
NCT ID NCT05509582
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to give people who had a stem cell transplant and developed low blood cell counts (anemia, low platelets) continued access to the drug fostamatinib. Only those who responded well in a prior study were eligible. The goal was to see if they could maintain stable blood cell levels for up to 21 months. However, the study was withdrawn before enrolling any participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Started
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Nov 2025
- Finished
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Nov 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Subjects who were enrolled on phase II trial of fostamatinib and deemed responders at the time of rollover to the extended access trial which is defined as: * Hemoglobin \>= 9 g/dL (or at least \>= 1 g/dL above baseline) in subjects enrolled with posttransplant anemia without transfusion support, at least once during the 12-week phase II trial. OR --Platelets \>= 30 X 10\^9/L (or at least \>= 10 X 10\^9/L above baseline) without transfusion support, at least once during the 12-week phase II trial, in subjects enrolled with posttransplant thrombocytopenia OR --Either of the above criteria in subjects with posttransplant Evans syndrome * Completed the end of study visit (week 12) on the initial protocol (A Phase II Study of Syk-inhibition using Fostamatinib to treat Post-Transplant Immune-mediated Cytopenias). * Female patients of reproductive potential agree to avoid pregnancy through abstinence or the use two forms of highly effective birth control during and for 1 month after the last study treatment and agree not to donate eggs during this time. * Male patients of reproductive potential agree to avoid pregnancy of a partner through abstinence or the use two forms of highly effective birth control during and for 1 month after the last study treatment and agree not to donate sperm during this time. EXCLUSION CRITERIA: * Severe psychiatric illness or mental deficiency sufficient to make making informed consent impossible * Positive pregnancy test for women of childbearing age within 1 week or being actively lactating * Uncontrolled hypertension (systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg) * ALT or AST \>3 times the upper limit of normal * Patients who have a history of medical disorders, that in the investigator's opinion, could affect the conduct of the study or the absorption, metabolism or excretion of the study drug are excluded. * Patients with evidence of graft rejection (based on clinical suspicion supported by BM biopsy data and/or chimerism studies and/or MLR) * Neutropenia, defined as absolute neutrophil count \<= 1.0 X 10\^9/L * Non-immune mediated cytopenias. Etiologies including, but not limited to, cytopenias due to HIV infection, lymphoproliferative disorders, myelodysplasia/acute leukemia, drug-induced thrombocytopenia, thrombotic microangiopathies, acute bleeding, consumptive coagulopathy, fever, infections leading to cytopenia, medications induced cytopenias, thrombotic microangiopathies (disseminated intravascular coagulation), splenomegaly or hemophagocytic lymphohistiophagocytosis, relapse of primary disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New hope for transplant patients: drug may tame chronic GVHD without steroids
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- New immune therapy combo aims to tame chronic GVHD in Steroid-Resistant patients