Phase I study of WT1-expressing human artificial adjuvant vector cells (aAVC-WT1) for patients with relapsed or refractory acute myeloid leukemia
- Conditions
- relapsed or refractory acute myeloid leukemia (AML)
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
Acute promyelocytic leukemia, BCR-ABL-positive leukemia Central nervous system infiltration/extramedullary AML Sustained non-hematological toxicity ( >= Grade 2) related to prior therapy for AML Clinically relevant graft-versus-host disease required for treatment Duration from prior therapy to administration: 1) Systemic immunosuppressive drugs including steroids <= 14 days 2) Investigational drugs, products, or medical devices <= 4 weeks 3) Hematopoietic stem cell transplantation <= 8 weeks 4) Chemotherapy (excluding hydroxyurea for leukemia control) Laboratory examination <= 14 days prior to registration: 1) AST/ALT >= 3 times upper limit of normal level (ULN) 2) Total serum bilirubin level >= 2 times ULN 3) Lymphocytes (peripheral blood) <= 5.0 x 10^2 /microliter 4) Estimated glomerular filtration rate < 30 mL/min 5) SpO2 < 94% (room air) Other active malignancies Angina pectoris, acute myocardial infarction, congestive heart failure (>= NYHA class 3), or severe abnormality on electrocardiography <= 12 weeks prior to 1st administration Poor control hypertension, interstitial pneumonia, pulmonary fibrosis, chronic obstructive pulmonary disease (>= stage 3) Disseminated intravascular coagulation Active/poor control infection, HIV infection Active hepatitis B/C virus infection, other active liver disease Congenital/acquired immune deficiency Pregnant, possible pregnant, breast feeding women Poor control diabetes mellitus Known hypersensitivity to reagents (human albumin, etc.), additives (galactose/ceramide), antibiotics (streptomycin/gentamicin) and heterologous proteins (fetal bovine serum/porcine trypsin) Principal investigator/co-investigator judgement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (1) Occurence of Dose Limiting Toxicity and determination of Maximum Tolerated Dose (2) Exploration of adverse events (3) Statistical analysis on examinations related to safety evaluation
- Secondary Outcome Measures
Name Time Method Immunological effects (NKT cell-specific immune response and amplification rate) Clinical efficacy (1) Hematological effect: Response rate(CR, PR, CRi) (2) Longitudinal change of WT1 mRNA copies (3) Overall survival