DANCE-anti-AM

Phase 1

• Conditions: AML: Acute Myeloid leukemia/ cancer of blood and bone marrow; MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000698-54-NL
• Lead Sponsor: Prinses Maxima Centrum voor kinderoncologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-18
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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 3 patients =16 years of age), part B 0- =30 years of age

Are the trial subjects under 18? yes
Number of subjects for this age range: 29
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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®) plasters
-Patients included in other intervention studies influencing the endpoints of this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified