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

Recruiting now · Phase 2

Conditions studied: Severe Aplastic Anemia, Cyclophosphamide Reduced-dose, Immunosuppressive Therapy

In brief

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.

Key facts

Study ID

NCT06695741

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

75

Starts

2024-11-01

Expected to finish

2027-06-30

Last updated by the study team

2024-11-19

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Red Blood Cell Disorders Center and Regenerative Medicine Center — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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