Search / Trial NCT00001626

Comparing Therapies for the Treatment of Severe Aplastic Anemia

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Nov 3, 1999

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Severe Aplastic Anemia Immunosuppression

Description

Severe aplastic anemia (SAA) is a disorder with a poor prognosis if untreated. Current accepted therapeutic strategies include bone marrow transplantation (BMT) and immunosuppression, both offering cure or amelioration in the majority of patients. Although BMT is successful using human leukocyte antigen (HLA) matched sibling bone marrow, the 25% probability of finding an HLA identical sibling within a family renders this approach available to only a minority of patients. BMT utilizing HLA-matched, unrelated donors carries a high risk of treatment failure along with considerable toxicity. Wh...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • Severe aplastic anemia confirmed at NIH by:
  • Bone marrow cellularity less than thirty percent (excluding lymphocytes).
  • At least two of the following:
  • Absolute neutrophil count less that 500/mm(3);
  • Platelet count less than 20,000/mm(3);
  • Reticulocyte count less than 60,000/mm(3).
  • EXCLUSION CRITERIA:
  • Serum creatinine greater than to 2.5 mg/dl.
  • Cardiac ejection fraction less than 45% by MUGA.
  • Underlying carcinoma (except local cervical, basal cell, squamous cell or melanoma).
  • Current pregnancy or unwilling to take oral contraceptives.
  • Diagnosis of Fanconi anemia or other congenital bone marrow failure syndromes.
  • Evidence of a clonal disorder on cytogenetics.
  • HIV positivity.
  • Inability to understand the investigational nature of the study.
  • Patients who are moribund or have hepatic, renal, cardiac, metabolic or other concurrent diseases of such severity that death within 7-10 days is likely.
  • Previous treatment with ATG, or cyclophosphamide.

Attachments

readout_NCT00001626_2024-03-02.pdf

4.5 MB

NCT00001626_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

12 weeks.

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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