Actively Recruiting
Clinical Study of DC-AML Cells in the Treatment of Acute Myeloid Leukemia
Led by Affiliated Hospital to Academy of Military Medical Sciences · Updated on 2021-08-20
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary aim of this innovative immunotherapy using WT1/hTERT/Survivin-loaded DCs is to determine whether this novel DC vaccination is safe and can significantly prevent clinical relapse and increase survival of acute myeloid leukemia (AML) patients by eradicating minimal residual disease, while maintaining its safety profile in this phase I trial.
CONDITIONS
Official Title
Clinical Study of DC-AML Cells in the Treatment of Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukemia (AML) according to WHO 2008 criteria
- Completed induction and consolidation chemotherapy and achieved complete remission with persistent minimal residual disease (MRD) defined by upregulated WT1 level and less than 5% blast cells in bone marrow
- Have MRD molecular relapse after complete remission following chemotherapy or after allogeneic stem cell transplant
- Leukemic cells express at least one antigen: WT1, hTERT, or survivin
- Karnofsky performance status 60% or higher or ECOG performance status 0 to 2
- Adequate organ and marrow function including leukocytes ≥3000/mcL, neutrophils ≥1500/mcL, platelets ≥100,000/mcL, hemoglobin ≥9.0 g/dL
- Total bilirubin within normal limits or <3.0 mg/dL if Gilbert's Syndrome
- Serum AST/ALT less than 2.5 times upper limit of normal
- Creatinine clearance ≥50 mL/min/1.73 m² if creatinine above normal
- Left ventricular ejection fraction ≥50% by MUGA scan
- Ability and willingness to provide informed consent
You will not qualify if you...
- Participation in any other interventional clinical trial during this study
- History or presence of other malignancies except those in remission for more than 5 years or highly likely cured
- Second invasive malignancy requiring treatment within last 2 years
- Systemic immunodeficiency including AIDS or primary immunodeficiency
- Active hepatitis B or C infection
- Use of immunosuppressive drugs including corticosteroids
- Autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues interfering with study compliance
- Allergy to human albumin or IL-2 or severe allergic reactions to similar compounds
- Pregnancy or breastfeeding
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
Beijing, Beijing Municipality, China, 100071
Actively Recruiting
Research Team
S
Sun Yao, M.D.,Ph.D.
CONTACT
W
Wang Yu xin, M.D.
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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