Actively Recruiting
Phase 1 Study of Chemotherapy Combining With HLA-mismatched G-CSF Mobilized Peripheral Blood Mononuclear Cell Infusion as a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed and Refractory Leukemia
Led by Beijing 302 Hospital · Updated on 2025-12-22
5
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving chemotherapy and infusion of HLA-mismatched granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood mononuclear cells (GPBMCs) as a bridge to allogeneic hematopoietic stem cell transplantation (allo-HSCT) for patients with relapsed or refractory leukemia. This Phase 1 study aims to assess the safety, tolerability, and early effectiveness of this approach, with a focus on reducing leukemia burden before transplantation. The study is sponsored by Beijing 302 Hospital and will follow patients for outcomes related to adverse events and survival. Participants will first receive chemotherapy regimens that may include drugs such as fludarabine, cytarabine, venetoclax, and others, combined with infusion of HLA-mismatched GPBMCs from a sibling or unrelated donor. After this initial step, patients will undergo allo-HSCT using stem cells from an HLA-matched sibling, haploidentical, or unrelated donor. The transplantation process includes conditioning treatments and medications to prevent graft-versus-host disease (GVHD). During the study, participants will be closely monitored for treatment-related side effects including GVHD, infections, organ dysfunction, and blood-related toxicities up to two years after transplant. Researchers will also assess survival outcomes and disease progression for up to four years. The study includes regular evaluations such as clinical exams and laboratory tests to track participants' health and response to therapy throughout the treatment and follow-up periods.
CONDITIONS
Brief 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, male or female, any race or ethnicity
- Confirmed diagnosis of relapsed or refractory leukemia according to WHO 5th edition classification
- Adequate liver function: ALT and AST ≤ 3 times upper limit of normal, total bilirubin ≤ 1.5 times upper limit
- Adequate kidney function: serum creatinine ≤ 2 times upper limit of normal or creatinine clearance ≥ 40 mL/min
- Left ventricular ejection fraction (LVEF) above 50% measured by echocardiogram
- Availability of an HLA-mismatched donor aged 18 or older for first-step GPBMC infusion
- Availability of a qualified donor aged 18 or older for allo-HSCT (matched sibling, 9-10/10 loci matched unrelated, or haploidentical donor)
- Donor meets institution criteria and is able to tolerate collection procedure
- Subject or legal representative signs informed consent form
- Donor signs informed consent form
You will not qualify if you...
- Uncontrolled infection or bleeding
- Significant cardiovascular disease such as uncontrolled arrhythmias, congestive heart failure, recent myocardial infarction within 6 months, or NYHA class 3 or 4 heart disease
- Uncontrolled autoimmune disease or requiring immunosuppression treatment
- History of severe blood infusion reaction
- Nursing women, women of childbearing potential who are pregnant or unwilling to use contraception
- Psychiatric disorder or cognitive impairment likely to affect protocol adherence
- Major surgery within 4 weeks prior to enrollment
- Life-threatening illness other than leukemia or uncontrolled intercurrent illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies based on chemotherapy and transplantation scheduling
Participants receive chemotherapy combined with HLA-mismatched GPBMC infusion to reduce leukemia burden, followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) according to protocol.
Multiple visits including chemotherapy sessions, GPBMC infusion, and allo-HSCT procedure
Duration - Up to 4 years
Participants are monitored for treatment-related adverse events including graft-versus-host disease, infections, organ dysfunction, hematological toxicity, and overall survival up to 4 years after treatment.
Regular visits for monitoring during the follow-up period
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
Y
Yangyang Lei, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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