Cyclophosphamide Added to Standard Immunosuppressive Therapy With Herombopag as Front-line Therapy in Patients With Severe Aplastic Anemia

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Active, not recruiting

Phase 2

Conditions

Severe Aplastic Anemia

Treatments

Drug: Cyclophosphamide added to standard immunosuppressive therapy with herombopag

Study type

Interventional

Funder types

Other

Identifiers

NCT05975996

IIT2023038

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.