Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia
Megadott ok: No significant improvement in efficacy was observed.
A legfontosabb adatok
- Fázis
- 2. fázis
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A vizsgálat adatai
- Ki végzi
- Institute of Hematology & Blood Diseases Hospital, China
- Azonosító
- NCT06695741
- A regiszteradat frissítve
- 2026. november 4.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy as Front-line Therapy in Patients With Severe Aplastic Anemia
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.
Bevonási feltételek: 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.
Kizáró feltételek: Previously received immunosuppressive therapy > 4 weeks; Previously treated with TPO-RA > 4 weeks; 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; Have an allergy or intolerance to anti-lymphocyte globulin, cyclosporine, herombopag or cyclophosphamide; Pregnant or breast-feeding patients; Patients considered to be ineligible for the study by the investigator for reasons other than the above.