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Wilms’ tumor (WT1) antigen-targeted dendritic cell vaccination to prevent relapse in adult patients with acute myeloid leukemia: a multicenter randomized phase II trial
EU CTIS ID: 2024-515292-35-00
What this study is testing
Clinical response: To determine the clinical efficacy of WT1 mRNA-electroporated DC vaccination as a post-remission strategy to prevent relapse and prolong overall survival in adult AML patients
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO): A) All French-American-British (FAB) subtypes (except for M3 (acute promyelocytic leukemia)) B) All cases of de novo AML or secondary AML with ≥20 % blasts in peripheral blood and/or bone marrow (except for AML secondary to myeloproliferative neoplasms (MPN) and AML secondary to exposure of leukemogenic agents (therapy-related (t)-AML) unless treated with CPX-351 chemotherapy or hypomethylating agents combined with venetoclax)
- Adult (≥18 years) at very high risk of relapse according to A) Age ≥60 years, and/or B) Adverse biological features (e.g. adverse cytogenetics, adverse morphological features, adverse molecular features, hyperleukocytosis (>100000 cells/µL)), and C) Ineligible for or unwilling to receive hematopoietic stem cell transplantation
- Completion of one of the following treatment options: I) Intensive chemotherapy: [(1) At least one cycle of induction chemotherapy and one cycle of consolidation chemotherapy (low-dose cytarabine as consolidation therapy is allowed) OR (2) One to two cycles of CPX-351 induction treatment and up to two cycles of CPX-351 consolidation treatment] OR II) Low-intensity chemotherapy: [(3) At least two cycles to maximum six cycles of hypomethylating agents (HMA) whether or not combined with venetoclax (VEN) OR (4) At least two cycles to maximum six cycles of low-dose cytarabine (LDAC) combined with venetoclax]; resulting in: A) Morphological complete remission (CR) (i.e. bone marrow blast count <5% with neutrophil count >1000 cells/µL and platelet count >100,000 cells/µL) OR B) Morphological complete remission with incomplete blood recovery (CRi) (i.e. bone marrow blast count <5% with neutrophil count <1000 cells/µL or platelet count <100,000 cells/µL. For the purpose of this study protocol, platelet count must be >50,000 cells/µL)
- WHO performance status: grade 0,1 or 2 at the time of enrollment (For definition of performance status, see: http://www.ecog.org/general/perf_stat.html)
- Absence of any psychological, familial, sociological, geographical or physical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before study entry
You likely can't join if
- Participation in any other interventional clinical trial during the study period
- History or concomitant presence of any other malignancy, except for: A) Non-melanoma skin cancer B) Carcinoma in situ of the cervix C) Any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment
- Known concomitant presence of any immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo
- Concomitant use of systemic corticosteroids in immunosuppressive doses (>1 mg/kg/day of prednisone, or equivalent dose for other corticosteroid preparations) or any other immunosuppressive agent. A minimum of 4 weeks must have elapsed between the last dose of immunosuppressive therapy and the first vaccination. Topical corticosteroids are permitted, except if applied at the sites of DC injection
- Pregnant or breast-feeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.