Actively Recruiting
UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-03-21
9
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to explore the safety and efficacy of UCMSC-Exo in consolidation chemotherapy-induced myelosuppression in patients with acute myeloid leukemia after achieving complete remission.
CONDITIONS
Official Title
UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 60 years old
- Diagnosed with acute myeloid leukemia (AML, excluding subtype M3) with complete remission
- Planning to receive consolidation chemotherapy (cytarabine or cytarabine-based regimen)
- Male or female
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Estimated survival of at least 3 months
- Adequate respiratory, cardiac, hepatic, and renal function
- No anti-cancer therapy within 2 weeks before enrollment and recovered from previous treatment toxicities to Grade 1 or below
- Agree to use medically recognized contraception during and for 6 months after treatment if of childbearing potential
You will not qualify if you...
- Central nervous system manifestations of acute myeloid leukemia at diagnosis
- Secondary acute myeloid leukemia
- Myelosuppression caused by conditions other than anti-cancer therapy
- Prior radiation therapy to sternum or pelvis
- Uncontrolled infection or active bleeding at enrollment
- Severe comorbidities affecting survival, such as cachexia or severe malnutrition
- Estimated survival of 48 hours or less
- Active hepatitis B or C infection
- History or current HIV infection
- Syphilis infection
- Use of immunosuppressants or organ transplant within last 6 months
- Participation in other clinical drug trials within 6 weeks before enrollment
- Previous participation in stem cell or exosome clinical research
- Concurrent use of agents inhibiting cell division with UCMSC-Exo infusion
- Severe allergies or known allergy to study drug components
- Contraindications to hematopoietic growth factors, blood transfusions, or anti-infective agents
- Pregnant or breastfeeding females
- Mental illness or drug abuse
- History of other malignancies within 3 years except hematological malignancies
- Poor compliance or inability to complete the study
- Other conditions judged by investigator to increase risk or interfere with the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
Q
Qiubai Li, Professor
CONTACT
D
Di Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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