No registrations found.
ID
Source
Brief title
Health condition
Acute myeloid leukemia
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the prognostic value of (LSC) MRD in PB compared to BM for relapse free survival (RFS) and overall survival (OS).
Secondary outcome
Secondary outcome is to determine the correlation between MRD in PB and BM and determine the influence of dilution by comparing MRD percentage between the different BM tubes taken from one puncture and the PB sample.
Background summary
We aim to determine and compare MRD in BM and PB with our current qualified MRD test. The study takes place at the Amsterdam UMC location VUmc and AMC. We take two extra tubes (14 ml total) of heparin blood at the same day as the planned BM sample in AML patients. We will also examine the correlation between the two samples. Moreover, we will examine the influence of hemodilution by numbering the BM collection tubes. We expect to find a lower sensitivity, which may be counterbalanced by an increase in specificity in PB, making it still relevant for prediction of relapse.
Study objective
We expect to find a lower sensitivity, which may be counterbalanced by an increase in specificity in PB, making it still relevant for prediction of relapse.
Study design
At least one
Inclusion criteria
Patient with:
- a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML), or
- acute leukemia’s of ambiguous lineage according to WHO 2008 or
- a diagnosis of refractory anemia with excess of blasts (MDS) and IPSS-R score > 4.5.
Treated according to HOVON clinical trials with intensive chemotherapy;
Age 18 yr or older;
A bone marrow aspiration has been scheduled;
WHO performance status 0, 1 or 2;
Written informed consent.
Exclusion criteria
Pregnant or lactating females;
Unwilling or not capable to use effective means of birth control.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9690 |
| Other | METC VUmc : METC2021.0021 |