Cyclophosphamide Added to Standard Immunosuppressive Therapy With Herombopag as Front-line Therapy in Patients With Severe Aplastic Anemia
Phase 2
Recruiting
- Conditions
- Severe Aplastic Anemia
- Interventions
- Registration Number
- NCT05975996
- 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 cyclophosphamide for severe aplastic anemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experiemental Cyclophosphamide added to standard immunosuppressive therapy with herombopag ALG/CsA(Cyclosporine) and herombopag and moderate-dose cyclophosphamide
- Primary Outcome Measures
Name Time Method Overall response rate Within 3 months Percentage of patients with hematological response. Hematological response includes complete rate, near complete rate(CR), very good partial response(VGPR), good partial response(GPR) and partial response(PR).
- Secondary Outcome Measures
Name Time Method Incidence of the adverse event Within 6 months Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event
Robust response Within 3 months Percentage of patients with robust response, including CR, near CR, VGPR and GPR.
Time to achieve robust hematological response Within 6 months All-cause mortality Within 3 months
Trial Locations
- Locations (1)
Regenerative Medicine Center
🇨🇳Tianjin, Tianjin, China