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Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia

RecruitingPhase 2Ages 12 Years - anyAllInstitute of Hematology & Blood Diseases Hospital…
NCT06695741 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective, single-center, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of anti-lymphocyte globulin plus herombopag in combination with the reduced dose of cyclophosphamide (hypo-CASH) for severe aplastic anemia.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subject has a diagnosis of naïve severe or very severe aplastic anemia * Male or female age ≥ 12 years * Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation. * ECOG performance status ≤2 * Willing and able to comply with the requirements for this study and written informed consent. Exclusion Criteria: * Previously received immunosuppressive therapy \> 4 weeks * Previously treated with TPO-RA \> 4 weeks * Have an allergy or intolerance to anti-lymphocyte globulin, cyclosporine, herombopag or cyclophosphamide. * Uncontrolled fungal, bacterial, or viral infection. Hepatitis-associated aplastic anemia is allowed; hepatitis B or C infection is permitted unless it causes severe liver failure. * Tested positive for HIV or syphilis * Presence of severe liver, kidney, or heart failure, or other life-threatening comorbidities. * History of radiotherapy and chemotherapy for malignant solid tumors in recent 5 years * Combined with other serious disorders * Pregnant or breast-feeding patients * Patients considered to be ineligible for the study by the investigator for reasons other than the above.
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What it tests

  • Reduced dose of cyclophosphamide combined with standard immunosuppressive therapy
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Where

1 site
Red Blood Cell Disorders Center and Regenerative Medicine Center
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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