relapsed or refractory acute myeloid leukemia (AML)
Conditions
Interventions
Intravenous administraion of aAVC-WT1 followed by 3+3 dose escalation scheme
Sponsors
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ability to give patients' consent by written informed consent form Age >= 20 Relapsed or refractory primary/secondary AML diagnosed by 2016 WHO classification Awareness of AML Peripheral blood WT-1 mRNA => 1500 copies/microgram ever before ECOG Performance Status <= 2 Life expectancy >= 12 weeks Submission of preserved specimens at screening and newly collected bone marrow/bone marrow aspiration
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactCenter for Translational Research
The Institute of Medical Science, The University of Tokyo Center for Translational Research, IMSUT Hospital
Outcome results
None listed