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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00065260 |
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Date of registration:
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18/07/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia
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Scientific title:
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A Randomized Trial of Immunosuppression in Aplastic Anemia Patients With Refractory Pancytopenia or Suboptimal Hematologic Response After h-ATG/CsA Treatment |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00065260 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Danielle M Townsley, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Heart, Lung, and Blood Institute (NHLBI) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
Severe aplastic anemia confirmed at NIH by:
Bone marrow cellularity less than 30% (excluding lymphocytes)
At least two of the following:
Absolute neutrophil count less than 500/microL;
Platelet count less than 20,000/ microL;
Reticulocyte count less than 60,000/ microL.
Severe aplastic anemia refractory to prior course(s) of h-ATG/CsA defined after 3 months
from treatment with less or equal to 4 years from receiving h-ATG.
OR
Suboptimal response to initial immunosuppression with h-ATG/CsA as defined by platelet and
reticulocyte count less than 50,000 /microL at 3 months.
Age greater than or equal to 2 years of age
EXCLUSION CRITERIA:
Diagnosis of Fanconi anemia.
Evidence of a clonal disorder on cytogenetics. Patients with super severe neutropenia (ANC
less than 200/microL) will not be excluded initially if results of cytogenetics are not
available or pending. If evidence of a clonal disorder is later identified, the subject
will go off study.
Prior treatment courses with rabbit ATG or high dose cyclophosphamide (200 mg/kg or
equivalent).
Infection not adequately responding to appropriate therapy.
Underlying immunodeficiency state including seropositivity for HIV.
Failure to discontinue the herbal supplements Echinacea purpurea or Usnea barbata (Old
Man's Beard) within two weeks of enrollment.
Previous hypersensitivity to Campath-1H or its components.
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.
Serum creatinine greater than 2.5 mg/dL.
Current pregnancy or lactation or unwillingness to take contraceptives.
Inability to understand the investigational nature of the study or give informed consent.
Age minimum:
2 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aplastic Anemia
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Intervention(s)
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Drug: r-ATG
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Drug: CsA
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Drug: Campath-1H
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Primary Outcome(s)
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No Longer Meeting Criteria for Severe Aplastic Anemia.
[Time Frame: 6 months]
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Secondary Outcome(s)
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Secondary Endpoints Will Include: Relapse; Clonal Evolution to Myelodysplastic Syndrome (MDS), Paroxysmal Nocturnal Hemoglobinuria (PNH) or Acute Leukemia
[Time Frame: months/years]
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Secondary ID(s)
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03-H-0249
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030249
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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