DANCE-anti-AM

Phase 1

• Conditions: AML: Acute Myeloid leukemia/ cancer of blood and bone marrow; MedDRA version: 19.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; MedDRA version: 19.0Level: LLTClassification code 10000887Term: Acute myeloid leukemia in remissionSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000827-94-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-12
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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) 52 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 (annex 1)
-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

Are the trial subjects under 18? yes
Number of subjects for this age range: 54
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subject who meets any of the following criteria will be excluded from participation in this study:
-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
-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 clinical trial of medicinal product
• Study Design: Not specified