Status:
ACTIVE_NOT_RECRUITING
Cyclophosphamide Added to Standard Immunosuppressive Therapy With Herombopag as Front-line Therapy in Patients With Severe Aplastic Anemia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Severe Aplastic Anemia
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
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 moderate-dose cyclo...
Eligibility Criteria
Inclusion
- Male or female age ≥ 12 years
- Subject has a diagnosis of naïve severe or very severe aplastic anemia
- ECOG performance status ≤2
- Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation.
- Willing and able to comply with the requirements for this study and written informed consent.
Exclusion
- Previously received immunosuppressive therapy \> 4 weeks
- Previously treated with TPO-RA \> 4 weeks
- Have an allergy or intolerance to either herombopag or cyclophosphamide.
- Have an allergy to ALG
- Uncontrolled systemic fungal, bacterial, or viral infection
- Poorly controlled hypertension (≥140/90mmHg) or diabetes (a fasting plasma glucose concentration ≥7.0mmol/L or a random venous plasma glucose concentration ≥11.1mmol/L)
- Abnormal liver or kidney function: ALT or AST \>3 ULN, or serum creatinine (sCr)≥ 2.5 ULN.
- History of radiotherapy and chemotherapy for malignant solid tumors
- 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.
Key Trial Info
Start Date :
July 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05975996
Start Date
July 10 2023
End Date
December 31 2025
Last Update
September 25 2024
Active Locations (1)
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1
Regenerative Medicine Center
Tianjin, Tianjin Municipality, China, 300131