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
- Conditions
- Pediatric AML patient elegible for allogeneic hematopoietic cell transplantation
- Registration Number
- NL-OMON27248
- Lead Sponsor
- niversity Medical Center Utrecht, The NetherlandsUMC Utrecht
- Brief Summary
de Haar C, Plantinga M, Blokland NJ, et al. Generation of a cord blood-derived Wilms Tumor 1 dendritic cell vaccine for AML patients treated with allogeneic cord blood transplantation. oncoimmunology. 2015;4(11):e1023973–12.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 54
•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 52 taken at diagnosis and/or relapse after (re-)induction chemotherapy.
•Indication for CB-HCT according to the UMC Utrecht guidelines
•Patients undergoing allo-HCT with stem cells derived from PBMCs or BM
•Patients who are pregnant or breast-feeding or unwilling to use adequate contraceptive methods
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoints:<br /><br>Part A, Safety: Occurrence of DLTs including aGvHD (according to Glucksberg criteria1) from the first vaccination (t=0) until 84 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 the first vaccination as compared to historical controls.<br>
- Secondary Outcome Measures
Name Time Method