Extension Study (Extended Access) of Syk-inhibition Using Fostamatinib to Treat Posttransplant Immune-mediated Cytopenias
Immune Mediated Anemia, Immune Mediated Thrombocytopenia, Chronic GVHD
About this trial
This is an interventional treatment trial for Immune Mediated Anemia focused on measuring Allogeneic Hematopoietic Stem Cell Transplant, Graft Versus Host Disease, Spleen Tyrosine Kinase (Syk) Inhibitor
Eligibility Criteria
- 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 Evan s 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.
Sites / Locations
- National Institutes of Health Clinical Center
Arms of the Study
Arm 1
Experimental
Fostamatinib Arm
The subjects will receive oral fostamatinib daily for up to 2 years.