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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Nov 16, 2024

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ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with severe aplastic anemia, a serious condition where the body doesn't produce enough blood cells. The researchers want to see if a combination of a lower dose of cyclophosphamide (a medication that helps suppress the immune system) with other treatments, specifically anti-lymphocyte globulin and herombopag, is safe and effective. This study is being conducted at one center and is currently looking for participants.

To be eligible for this trial, participants must be at least 12 years old and diagnosed with severe or very severe aplastic anemia. They should not have received any immunosuppressive therapy in the last 4 weeks, and they must be willing to follow the study's requirements and give informed consent. Participants will receive the study treatment and will be monitored to see how well it works and if there are any side effects. It's important for potential participants to know that certain health conditions or previous treatments may disqualify them from joining the study, so discussing eligibility with a healthcare provider is essential.

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Eligibility criteria

• 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.