Treatment guided by detection of Minimal Residual Disease after allogeneic stem cell transplantation in Acute Myeloid Leukaemia

Completed

• Conditions: acute myeloid leukemia; AML; 10024324

• Registration Number: NL-OMON38951
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 31

Inclusion Criteria

*Patients with Acute Myeloid Leukemia according to WHO classification 2008
*Age 18-75
*Indication for allogeneic stem cell transplantation based on risk group profile
*Related or unrelated 8/8 HLA matched donor available
*Presence of Leukemia Associated Phenotype(s) (LAPs)
*Written informed consent

Exclusion Criteria

-Myelodysplastic syndrome with refractory anaemia with excess blasts (RAEB)
Acute Promyelocytic Leukemia (AML M3)
-Absence of LAP(s)
-Previous allogeneic stem cell transplantation
-Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
*Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D)
*Severe neurological or psychiatric disease
*Significant hepatic dysfunction (serum bilirubin or transaminases * 3 times upper limit of normal) unless related to treatment
*Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration)
*Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
*Patient known to be HIV-positive
*Pregnant or breast-feeding female patients
*Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The cumulative incidence of (hematological) relapse</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>*Relapse free survival<br /><br>*Overall survival<br /><br>*Incidence of acute and chronic GVHD</p><br>