Decitabine in the conditioning strategy for AM

Phase 1

• Conditions: Acute myeloid leukemiaAML; MedDRA version: 17.0Level: LLTClassification code 10001941Term: AMLSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-000400-99-NL
• Lead Sponsor: Radboud university medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-20
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Inclusion criteria
•Patients eligible for allogeneic HCT, independent of age
•Patients of any age with a cytopathologically confirmed diagnosis according to WHO classification of newly diagnosed AML (not APL = AML-M3), de novo AML or secondary AML
•in first complete remission (CR1)
•Poor risk or very poor risk subgroups
•WHO performance status = 2
•Written informed consent

Poor risk is defined as: - Normal karyotype, WBC = 100, not in CR after first cycle of chemo
- Normal karyotype, WBC > 100
- Abnormal karyotype, non CBF, MK, no abn 3q26, EVI1-

Very poor risk is defined as:- Non CBF, MK+
- Non CBF, abn eq26
- Non CBF, EVI1+
- Non CBF, high Flt3-ITD allelic burden

CBF = Core Binding Factor
MK = monosomal karyotype

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Exclusion criteria
•Patient not in CR1
•Patients who have senile dementia, mental impairment of any other psychiatric disorder that prohibits the patient from understanding and giving informed consent
•Active serious infections like HIV, HBV and HCV
•Patient is unwilling to use contraceptive techniques during and for 12 months following treatment
•Female patient who is pregnant or breastfeeding

Study & Design

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