UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia

INCLUSION CRITERIA In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Age ≥2 years to ≤21 years * Child should be receiving ongoing care with pediatric hematology/oncology provider. * Confirmed Diagnosis of SAA and other related conditions based on following criteria. Diagnosis of severe Aplastic anemia (newly diagnosed or refractory based on history of prior treatments) is established if bone marrow cellularity \<25% to 30% and at least two of the following criteria are met: (a) absolute neutrophil count \<0.5 × 10\^9 /L, (b) platelet count \<20 × 10\^9/L, and (c) hemoglobin \<8 g/dL. In the event bone marrow cellularity is \>30% but patient presents with severe pancytopenia and its complications; the diagnosis of SAA will be considered at the discretion of PI. For relapsed or refractory AA, minor variations in hematological parameters will be acceptable, e.g., platelet count of \<50 x 10\^9/L or hemoglobin of ≤9 g/dL. OR Diagnosis of refractory aplastic anemia will include a confirmed diagnosis of SAA and the clinical assessment by the treating physician that the patient has not responded to the frontline IST by 6 months. OR Diagnosis of relapsed aplastic anemia will be determined by previous diagnosis of SAA and the prior history of successful hematologic response to IST with subsequent loss of response and/or requirement of supportive therapy\*. \*Adequate organ function within 7 days of enrollment defined…