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A phase I/II post-cord blood HCT dendritic cell vaccination trial directed against WT1 for pediatric and young adult acute myeloid leukemia: the U-DANCE-anti-AML trial.
EU CTIS ID: 2024-517922-24-00
What this study is testing
The primary objective of Part A is to assess the safe dose for CBDC vaccination after CBT, defined by the occurrence of dose limiting toxicities (DLTs). The DLT evaluation period lasts from the first vaccination until 84 days after the third CBDC vaccination. The primary objective of Part B is to demonstrate an increase of 20% ( from 50% to 70%) in the WT1+ AML relapse-free survival rate using a WT1-loaded CBDC vaccine, at one year after the first vaccination. A historic cohort (2010-2015) from patients who received a CBT but not a CBDC vaccination was used as reference data for the Simon-2-stage design.
- Human Pharmacology (Phase I)- First administration to humans
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
- AML patients eligible for allo-HCT according to standard-of-care guidelines, with overexpression of WT1 mRNA in an AML sample (>50 copies WT1/10^4 copies ABL for PB, and >250 copies WT1/10^4 copies ABL for BM) 1 taken at diagnosis and/or relapse after (re-)induction chemotherapy.
- Indication for CB-HCT according to the Transplant Center guidelines.
- CB selection criteria: the 80% fraction of the unit should contain a minimum total nucleated cell number of 3x10^7 NC/Kg criteria for any match grade (before cryo-preservation). Preferable CD34+/Kg dose: > 1x10e5 in the 80%.
- The whole CB unit should contain more than 7.5x10^6 total CD34+ before freeze.
- Karnofsky/Lansky score ≥70.
- Age limits for part A ≥12 and ≤30 years of age (first three patients ≥16 years of age) for part B: 0 and ≤30 years of age.
You likely can't join if
- Patients who are pregnant or breast-feeding or unwilling to use adequate contraceptive methods.
- Known allergies to compounds used in the CBDC production process or the local anesthetic “lidocaine-tetracaine (Rapydan®) and EMLA® (lidocaine/ prilocaine) plasters
- Patients included in other intervention studies influencing the endpoints of this study.
- No signed informed consent.
See the full eligibility criteria
- AML patients eligible for allo-HCT according to standard-of-care guidelines, with overexpression of WT1 mRNA in an AML sample (>50 copies WT1/10^4 copies ABL for PB, and >250 copies WT1/10^4 copies ABL for BM) 1 taken at diagnosis and/or relapse after (re-)induction chemotherapy.
- Indication for CB-HCT according to the Transplant Center guidelines.
- CB selection criteria: the 80% fraction of the unit should contain a minimum total nucleated cell number of 3x10^7 NC/Kg criteria for any match grade (before cryo-preservation). Preferable CD34+/Kg dose: > 1x10e5 in the 80%.
- The whole CB unit should contain more than 7.5x10^6 total CD34+ before freeze.
- Karnofsky/Lansky score ≥70.
- Age limits for part A ≥12 and ≤30 years of age (first three patients ≥16 years of age) for part B: 0 and ≤30 years of age.
- Signed informed consent.
- Patients who are pregnant or breast-feeding or unwilling to use adequate contraceptive methods.
- Known allergies to compounds used in the CBDC production process or the local anesthetic “lidocaine-tetracaine (Rapydan®) and EMLA® (lidocaine/ prilocaine) plasters
- Patients included in other intervention studies influencing the endpoints of this study.
- No signed informed consent.
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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
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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.