Actively Recruiting
Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-11-19
75
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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 the reduced dose of cyclophosphamide (hypo-CASH) for severe aplastic anemia.
CONDITIONS
Official Title
Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Red Blood Cell Disorders Center and Regenerative Medicine Center
Tianjin, Tianjin Municipality, China, 301617
Actively Recruiting
Research Team
H
Hong Pan, MD
CONTACT
J
Jingyu Zhao, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here