Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia
NCT ID: NCT06695741
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2024-11-01
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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hypo-CASH
ALG/CsA and herombopag and reduced dose of cyclophosphamide
Reduced dose of cyclophosphamide combined with standard immunosuppressive therapy
Severe aplastic anemia patients will receive a daily dose of Anti-lymphocyte globulin (25mg/kg) for the initial five days at the beginning of the treatment. Cyclosporine will be administered daily at a dosage of 3-5mg/kg. Herombopag will be administered daily at a dosage of 15mg starting from the first day of treatment and continuing for a duration of six months. Cyclophosphamide (20mg/kg) will be administered on days 15-16.
Interventions
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Reduced dose of cyclophosphamide combined with standard immunosuppressive therapy
Severe aplastic anemia patients will receive a daily dose of Anti-lymphocyte globulin (25mg/kg) for the initial five days at the beginning of the treatment. Cyclosporine will be administered daily at a dosage of 3-5mg/kg. Herombopag will be administered daily at a dosage of 15mg starting from the first day of treatment and continuing for a duration of six months. Cyclophosphamide (20mg/kg) will be administered on days 15-16.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Jun Shi
Director of the Red Blood Cell Disorders Center & Director of the Regenerative Medicine Clinic
Locations
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Red Blood Cell Disorders Center and Regenerative Medicine Center
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Hypo-CASH-2024
Identifier Type: -
Identifier Source: org_study_id
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