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

Phase 2

Not yet recruiting

• Conditions: AML: Acute Myeloid Leukemia/ cancer of blood and bone marrow; 10024324

• Registration Number: NL-OMON55718
• Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 54

Inclusion 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) taken at diagnosis
and/or relapse (re-)induction chemotherapy.
- indication for CB-HCT according to the Prinses Maxima Centrum / UMC Utrecht
guidelines
- CB selection criteria: the 80% fraction of the unit should contain a minimum
total nucleatd cell number of 3x10^7 NC/Kg criteria for any match grade (before
cryo-preservation). Preferable CD34+/Kg dose: >1x10e5 in the 80% fraction
- The whole CB unit should contain more than 7.5x10^6 total CD34+ before freeze
- Karnofsky/Lansky score >=70
- Age limits for part A (safety run) only: >=12 - <=30 years of age (first thee
patients >16 years of age), part B 0- <=30 years of age

Exclusion Criteria

-Patients who are preganant or breast-feeding or unwilling to use adequate
contraceptive methods
-Known allergies to compound used in the CBDC production process or the local
anesthetic lidocaïne-tetracain (Rapydan®) and EMLA® (lidocaine/ prilocaine)
plasters
-Patients included in other intervention studies influencing the endpoints of
this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints:<br /><br><br /><br>Part A: Safety: Occurrence of DLTs from the first vaccination (t=0) until 84<br /><br>days after the third CBDC vaccination<br /><br><br /><br>Part B: Activity: One-year WT1+ AML relapse-free survival rate from the time of<br /><br>the first vaccination as compared to historical controls.</p><br>