A phase IIa study of aAVC-WT1 therapy to treat acute myeloid leukemia with MRD-positive complete remission or partial remission and high-risk myelodysplastic syndromes

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2033200305

Enrollment

Registered

2021-01-15

Start date

2021-11-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML with MRD-positive complete remission or partial remission and high-risk MDS

Interventions

Intravenous administraion of aAVC-WT1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Ability to give patients' consent by written informed consent form 2.Age >= 20 3.AML with MRD-positive complete remission or partial remission and high-risk MDS by 2016 WHO classification 4.Awareness of AML or MDS 5.Peripheral blood WT-1 mRNA => 50 copies/microgram ever before 6.In patients with Hematological CR, one of the following 1) and 2) was observed : 1) Blood WT-1 mRNA => 50 copies/microgram 2) In the quantitative analysis of disease-specific mRNAs (one or more of RUNX1-RUNX1T1, DEK-NUP214, NUP98-HOXA9, CBFB-MYH11, KMT2A-MLLT3, KMT2A-AFDN) caused by chromosomal abnormalities using bone marrow or peripheral blood, disease-specific mRNAs => 50 copies/microgram. 7.ECOG Performance Status = 12 weeks

Exclusion criteria

Exclusion criteria: 1.Acute promyelocytic leukemia, BCR-ABL-positive leukemia 2.Central nervous system infiltration/extramedullary AML 3.Sustained non-hematological toxicity ( >= Grade 2) related to prior therapy for AML 4.Clinically relevant graft-versus-host disease required for treatment 5.Duration from prior therapy to administration: 1) Systemic immunosuppressive drugs including steroids = 3 times upper limit of normal level (ULN) 2) Total serum bilirubin level >= 2 times ULN 3) Lymphocytes (peripheral blood) = NYHA class 3), or severe abnormality on electrocardiography = stage 3) 10.Disseminated intravascular coagulation 11.Active/poor control infection, HIV infection 12.Active hepatitis B/C virus infection, other active liver disease 13.Congenital/acquired immune deficiency 14.Pregnant, possible pregnant, breast feeding women 15.Poor control diabetes mellitus 16.Known hypersensitivity to reagents (human albumin, etc.), additives (galactose/ceramide), antibiotics (streptomycin/gentamicin) and heterologous proteins (fetal bovine serum/porcine trypsin) 17.Principal investigator/co-investigator judgement

Design outcomes

Primary

Measure	Time frame
Safety 1)Exploration of adverse events 2)Statistical analysis on examinations related to safety evaluation	—

Contacts

Public ContactArinobu Tojo

Tokyo Medical and Dental University

tojo.adm@tmd.ac.jp+81-3-3813-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026