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A phase I/II post-cord blood HCT dendritic cell vaccination trial directed against WT1 for pediatric acute myeloid leukemia: the U-DANCE-anti-AML trial

Phase 2
Withdrawn
Conditions
AML: Acute Myeloid Leukemia/ cancer of blood and bone marrow
10024324
Registration Number
NL-OMON44046
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
54
Inclusion Criteria

-Pediatric 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 after (re-)induction chemotherapy.;-Indication for CB-HCT according to the UMC Utrecht 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% 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 and *17 years of age, and <18 years for part B of the study. ;-Signed informed consent

Exclusion Criteria

- Patients undergoing allo-HCT with stem cells derived from PBMCs or bone marrow;- 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®) 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
NameTimeMethod
<p>The primary endpoints:<br /><br><br /><br>Part A: Safety: Occurrence of DLTs including aGvHD (according to Glucksberg<br /><br>criteria) from the first vaccination (t=0) until 84 days after the third CBDC<br /><br>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>
Secondary Outcome Measures
NameTimeMethod
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