Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy as Front-line Therapy in Patients With Severe Aplastic Anemia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 the reduced dose of cyclophosphamide (hypo-CASH) for severe aplastic anemia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Red Blood Cell Disorders Center and Regenerative Medicine Center
RECRUITING
Tianjin
Contact Information
Primary
Hong Pan, MD
panhong@ihcams.ac.cn
15822458611
Backup
Jingyu Zhao, MPH
zhaojingyu@ihcams.ac.cn
13752253515
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 75
Treatments
Experimental: hypo-CASH
ALG/CsA and herombopag and reduced dose of cyclophosphamide
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China