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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27188

Enrollment

Registered

2013-03-28

Start date

2013-04-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML MRD Allogeneic stem cell transplantation

Interventions

Based on MRD immune suppressive therapy consisting of Mycophenolate Mofetil and Cyclosporine A will be withdrawn early compared to standard practise. Duration of Ciclosporine A and Mycophenolate Mofet

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Acute Myeloid Leukemia according to WHO classification 2008; 2. Age 18-75; 3. Indication for allogeneic stem cell transplantation based on risk group profile; 4. Related or unrelated 8/8 HLA matched donor available; 5. Presence of Leukemia Associated Phenotype(s); 6. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Myelodysplastic syndrome with refractory anaemia with excess blasts (RAEB); 2. Acute Promyelocytic Leukemia (AML M3); 3. Absence of LAP(s); 4. Previous allogeneic stem cell transplantation; 5. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease); 6. Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D); 7. Severe neurological or psychiatric disease; 8. Significant hepatic dysfunction (serum bilirubin or transaminases => 3 times upper limit of normal) unless related to treatment; 9. Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration); 10. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.); 11. Patient known to be HIV-positive; 12. Pregnant or breast-feeding female patients; 13. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Design outcomes

Secondary

Measure	Time frame
1. Relapse free survival; 2. Overall survival; 3. Incidence of acute and chronic GVHD.	—

Primary

Measure	Time frame
Cumulative incidence of (hematological) relapse.	—

Contacts

Public ContactE. Meijer

De Boelelaan 1117

+31 (0)20 4442604

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)