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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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17 May 2016 |
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Main ID: |
NCT02203396 |
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Date of registration:
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27/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic Anemia
OSP |
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Scientific title:
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A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic Anemia |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02203396 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Nie Neng |
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Address:
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Telephone:
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+86 22 23909023 |
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Email:
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docnn@163.com |
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Affiliation:
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Name:
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Nie Neng |
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Address:
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Telephone:
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Email:
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docnn@163.com |
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Affiliation:
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Name:
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Zheng Yizhou, M.D., Ph.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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Anemia Therapeutic Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Newly diagnosed SAA (according to the standard criteria)
1. Bone marrow cellularity less than 30% (excluding lymphocytes)
2. At least two of the following: Absolute neutrophil count less than 500/ uL;
Platelet count less than 20,000/ uL; Absolute reticulocyte count less than
20,000/ uL.
- Age greater than or equal to 6 years old
Exclusion Criteria:
- Serum creatinine greater than 2.5 mg/dL
- Underlying carcinoma (except local cervical, basal cell, squamous cell)
- Prior immunosuppressive therapy with ATG, antilymphocyte globulin (ALG), or high dose
cyclophosphamide.
- Current pregnancy or lactation or unwillingness to take oral contraceptives or use an
effective method of birth control.
- Diagnosis of Fanconi anemia or other congenital bone marrow failure syndromes
- Evidence of a clonal disorder on cytogenetics. Patients with super severe neutropenia
(ANC less than 200/uL) will not be excluded if results of cytogenetics are not
available or pending.
- Underlying immunodeficiency state including seropositivity for HIV
- Inability to understand the investigational nature of the study or give informed
consent
- 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.
Age minimum:
6 Years
Age maximum:
70 Years
Gender:
Both
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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: rabbit ATG, Cyclosporine, Levamisole
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Primary Outcome(s)
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the response and complete remission rate with Optimized Standard Protocol.
[Time Frame: month +6]
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Secondary Outcome(s)
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Relapse rate, sustained response (SR), survival, and clonal evolution to myelodysplasia and acute leukemia.
[Time Frame: month +12, month +60]
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Secondary ID(s)
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ATGIIT201401
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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