At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of moderate aplastic anemia with hypocellular bone marrow and depression of at least 2 out of 3 blood counts: ANC ≤1200/mm³, platelets ≤70,000/mm³, or hemoglobin ≤8.5 g/dL
- ✓Diagnosis of pure red cell aplasia defined by anemia, reticulocyte count ≤50,000/mm³, and absent or decreased marrow erythroid precursors, requiring RBC transfusions
- ✓Diagnosis of Diamond-Blackfan anemia defined by anemia, reticulocyte count ≤50,000/mm³, and absent or decreased marrow erythroid precursors diagnosed at early age, requiring RBC transfusions
- ✓For moderate aplastic anemia: age ≥18 years. For PRCA/DBA: age ≥2 years and weight >12 kg
- ✕Diagnosis of Fanconi's anemia or other congenital bone marrow failure syndromes except Diamond-Blackfan anemia
- ✕History of cytogenetic abnormality indicating myelodysplasia (MDS)
- ✕Active infection not adequately responding to appropriate therapy
- ✕HIV positivity or positive anti-hepatitis B core antibody (anti-HBc) or HBsAG
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of Recombinant Humanized Anti- Cluster of Differentiation Antigen 20 (Anti-CD20) Antibody (Rituximab) in Patients With Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia
In Brief
A Phase 2 clinical trial evaluating Rituximab for Anemia, Aplastic and 2 related conditions. Completed, enrolled 11 participants across 1 site.
Detailed Summary
This study will test whether the immune-suppressing drug rituximab can increase blood counts and reduce the need for transfusions in patients with moderate aplastic anemia, pure red cell aplasia, or Diamond Blackfan anemia. These are rare and serious blood disorders in which the immune system turns against bone marrow cells, causing the bone marrow to stop producing red blood cells in patients with pure red cell aplasia and Diamond Blackfan anemia, and red blood cells, white blood cells and platelets in patients with aplastic anemia. Rituximab is a laboratory-made monoclonal antibody that recognizes and destroys white blood cells called lymphocytes that are responsible for destroying bone marrow cells in these diseases. The drug is currently approved by the Food and Drug Administration for treating patients with B-cell non-Hodgkin lymphoma, a disease of white blood cells.
Study Details
Timeline
Interventions
Rituximab (Rituxan) 375mg/m2 intravenous infusion. The infusion will be once every week for a total of 4 doses.