Status:
COMPLETED
Three Immunosuppressive Treatment Regimens for Severe Aplastic Anemia
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Immunosuppresion
Thrombocytopenia
Eligibility:
All Genders
2+ years
Phase:
PHASE2
Brief Summary
Severe aplastic anemia (SAA) is a life-threatening bone marrow failure disorder characterized by pancytopenia and a hypocellular bone marrow. Allogeneic bone marrow transplantation offers the opportun...
Detailed Description
Severe aplastic anemia (SAA) is a life-threatening bone marrow failure disorder characterized by pancytopenia and a hypocellular bone marrow. Allogeneic bone marrow transplantation offers the opportun...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Severe aplastic anemia characterized by bone marrow cellularity less than 30% (excluding lymphocytes) and at least two of the following:
- Absolute neutrophil count less than 500/microliter
- Platelet count less than 20,000/microliter
- Absolute reticulocyte count less than 60,000/microliter
- Age greater than or equal to 2 years old
- Weight greater than 12 kg
- EXCLUSION CRITERIA:
- Diagnosis of Fanconi's anemia
- Evidence of a clonal disorder on cytogenetics. Patients with super severe neutropenia (ANC less than 200/microliter) will not be excluded initially if cytogenetics are not available or pending. If evidence of a clonal disorder is later identified, the patient will go off study.
- Prior immunosuppressive therapy with ATG, ALG, alemtuzumab, or high dose cyclophosphamide.
- Infection not adequately responding to appropriate therapy.
- Serologic evidence of HIV infection.
- Failure to discontinue the herbal supplements Echinacea purpurea or Usnea barbata (Old Man's Beard) within 2 weeks of enrollment.
- 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 7-10 days is likely.
- Potential subjects with cancer who are on active chemotherapeutic treatment or who take drugs with hematological effects will not be eligible.
- Current pregnancy, or unwillingness to take oral contraceptives or refrain from pregnancy if of childbearing potential.
- Not able to understand the investigational nature of the study or give informed consent.
Exclusion
Key Trial Info
Start Date :
November 28 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2016
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00260689
Start Date
November 28 2005
End Date
May 4 2016
Last Update
June 8 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892