Rituximab to Treat Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia

Completed · Phase 2

Conditions studied: Anemia, Aplastic, Red-Cell Aplasia, Pure, Anemia, Diamond-Blackfan

In brief

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.

Key facts

Study ID

NCT00229619

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

11

Starts

2005-09-01

Expected to finish

2010-06-01

Last updated by the study team

2018-09-18

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Current diagnosis of Fanconi's anemia or other congenital bone marrow failure syndromes except for DBA
• History of a cytogenetic abnormality indicating myelodysplasia (MDS)
• Active infection not adequately responding to appropriate therapy
• HIV positivity
• Positive anti- hepatitis B core antibody (antiHBc) or HBsAG
• History of clinically significant arrhythmia
• Known anaphylaxis or immunoglobulin E (IgE) mediated hypersensitivity to murine proteins or to any component of this product.
• Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy, or that death within the next month is likely
• Potential subjects with cancer who are on active chemotherapeutic treatment or who take drugs with hematological effects will not be eligible.
• History of recent or ongoing B19 parvovirus infection
• Psychiatric, affective, or other disorder that may compromise the ability to give informed consent or to cooperate in a research study.
• Pregnancy or lactation or unwillingness to take contraceptives
• Participation in any other investigational drug trial or exposure to other investigational agents (other than hematopoietic growth factors) within 30 days of study entry. Use of low dose immunosuppressive agents may continue at the PIs discretion provided that the patient has been taking this drug for at least 3 months.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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