Table of contents
- Trial overview
- Who the trial is for
- What the trial is studying
- Trial design and phase
- Outcomes being measured
- Status and comparison group
- Key patient terms
Trial overview
The clinical trial titled U-DANCE-anti-AML is a phase I/II post-cord blood HCT dendritic cell vaccination study directed against WT1 for pediatric and young adult acute myeloid leukemia.[1] It is listed as an interventional study and has a target enrollment of 54 participants.[1] The trial status is suspended.[1]
The study investigates Autologous Cord Blood-Derived Dendritic Cells Loaded With Wt1 Peptide Pool as a WT1-loaded CBDC vaccine given by intravenous injection.[1] The trial is focused on AML, which is described in the source as cancer of the blood and bone marrow.[1]
Who the trial is for
This trial is aimed at pediatric and young adult patients with AML.[1] The brief summary also says the study uses a historic cohort of patients who received cord blood transplant but did not receive the vaccine, showing that the trial is centered on the period after transplant.[1]
The condition is described more specifically as WT1+ AML in the study summary and primary outcome description.[1] In simple terms, this means the leukemia group being studied has the WT1 target that the trial is built around.[1]
What the trial is studying
The main question in Part A is whether the vaccine dose is safe after cord blood transplant.[1] Safety is checked by looking for dose-limiting toxicities, which are serious side effects that may limit treatment.[1]
Part B looks at activity, meaning whether the study treatment may help patients stay free of relapse longer.[1] The trial summary says the goal is to increase the one-year WT1+ AML relapse-free survival rate from 50% to 70% compared with historic controls.[1]
The source also states that the vaccine is given after cord blood transplantation, which is a transplant that uses blood from an umbilical cord to help rebuild blood-forming cells.[1] This tells us the study is not testing the disease itself, but a post-transplant vaccination approach.[1]
Trial design and phase
The trial is described as a phase I/II study in the title, while the structured data lists the phase as Phase 1.[1] This means the study starts with early safety testing and then includes a second part that looks more closely at activity.[1]
The summary explains that the study uses a Simon 2-stage design for the second part.[1] In simple language, this is a step-by-step plan that checks early results before moving ahead.[1]
The first part of the study follows patients from the first vaccination until 84 days after the third CBDC vaccination for the safety check.[1] The first 6 patients receiving the dose judged safe are also included in the first stage of the phase 2 design.[1]
Outcomes being measured
The main safety outcome is the occurrence of DLTs from the first vaccination until 84 days after the third vaccination.[1] This outcome helps the researchers decide whether the dose can be used safely in the next part of the study.[1]
The main activity outcome is the one-year WT1+ AML relapse-free survival rate from the time of the first vaccination.[1] This means the study checks how many patients remain free from leukemia coming back during the first year after vaccination.[1]
The study compares this result with a historic group of patients from 2010 to 2015 who had cord blood transplant but did not receive a CBDC vaccination.[1] This comparison helps researchers see whether the trial group does better than earlier patients who had standard transplant care alone.[1]
Status and comparison group
The trial is currently listed as suspended.[1] In trial language, this means the study is not actively moving forward at the time shown in the source.[1]
Instead of using a live control group in the same study, the researchers use historic controls from earlier years.[1] These are past patient records used as a comparison group, which is common in some early studies when a randomized control group is not listed.[1]
Key patient terms
Interventional study: a study where participants receive a treatment or procedure that the researchers are testing.[1]
WT1: the target used in this trial to guide the vaccine approach.[1]
Relapse-free survival: the time a patient stays free from the cancer coming back.[1]
Primary outcome: the main result the study is designed to measure.[1]
Phase 1: an early trial phase that mainly checks safety and dose.[1]
