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

Conditions: Minimal residual disease after allogeneic stem cell transplantation in Acute Myeloid Leukaemia
MedDRA version: 15.1Level: LLTClassification code 10001941Term: AMLSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2013-000238-37-NL

Lead Sponsor: VU University medical center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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)
•Written informed consent

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 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To decrease the cumulative incidence of (hematological) relapse<br>;Secondary Objective: •To prolong relapse free survival<br>•To prolong overall survival<br>•To assess the incidence of acute and chronic GVHD<br>;Primary end point(s): -Cumulative incidence of (hematological) relapse<br>;Timepoint(s) of evaluation of this end point: every four weeks during 6 months from baseline

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Relapse free survival<br>-Overall survival<br>-Incidence of acute and chronic GVHD<br>;Timepoint(s) of evaluation of this end point: every four weeks during 6 months from baseline