Actively Recruiting
Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R/R Leukemia
Led by Beijing 302 Hospital · Updated on 2025-12-22
5
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of chemotherapy combining with HLA-mismatched G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion as a bridging therapy to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed and refractory (R/R) leukemia.
CONDITIONS
Official Title
Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R/R Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 15 years or older, any gender or race
- Confirmed diagnosis of relapsed or refractory leukemia according to WHO classification
- Adequate liver function: ALT and AST less than or equal to 3 times upper limit of normal, total bilirubin less than or equal to 1.5 times upper limit of normal
- Adequate kidney function: serum creatinine less than or equal to 2 times upper limit of normal or creatinine clearance at least 40 mL/min
- Normal heart function with left ventricular ejection fraction above 50%
- Availability of one HLA mismatched donor aged 18 or older for GPBMC infusion and another donor aged 18 or older qualified for allo-HSCT if needed
- Donors must meet institution criteria and be able to tolerate cell collection and provide informed consent
- Participant or legal representative must sign consent form to participate
You will not qualify if you...
- Uncontrolled infection or bleeding
- Significant cardiovascular disease including uncontrolled arrhythmias, congestive heart failure, recent heart attack within 6 months, or severe heart disease (NYHA class 3 or 4)
- Uncontrolled autoimmune disease or need for immunosuppressive treatment
- History of severe blood transfusion reactions
- Nursing women, women of childbearing potential with positive pregnancy test, or those unwilling to use contraception
- Psychiatric or cognitive conditions that may prevent protocol adherence
- Major surgery within 4 weeks before enrollment
- Life-threatening or uncontrolled illnesses other than leukemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital
Beijing, China, 100071
Actively Recruiting
Research Team
B
Bo Cai, MD
CONTACT
Y
Yangyang Lei, MD
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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