Assessment of Body, Liver and Labile Plasma Iron and Their Association With Outcome and Immunological Recovery in Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) Patients Undergoing Allogeneic Stem Cell Transplantation - ALLIVE (ALLogeneic Iron inVEstigators) Observational Trial

GWT-TUD

Status: Completed

Conditions: MDS and AML Prior to Allogeneic SCT

Treatments: Other: No intervention and study treatment

Study type: Observational

Funder types: Other

Identifiers

NCT01746147

ALLIVE-2012

Details and patient eligibility

About

The ALLIVE (ALLogeneic Iron inVEstigators) trial aims at quantifying the extent and dynamic change of LPI occurrence during conditioning and at identifying LPI-predictive peri-transplant parameters. Further points of interest are the improvement of systemic iron overload (SIO) diagnostics and the correlation of different SIO parameters with outcome after transplantation. The results of this trial will help to design prospective interventional studies addressing therapeutic options in patients at risk for SIO-associated toxicity during allogeneic stem-cell transplantation (allo-SCT).

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >= 18 years at the time of signing the informed consent form
• Signed informed consent
• Diagnosis of AML or MDS according to WHO classification
• Planned allogeneic stem cell transplantation after reduced intensity or myeloablative conditioning from related or unrelated donors
• At risk for iron toxicity as defined by ferritin >500 ng/ml and/or history of more than 10 RBC transfusions prior to allo-SCT

Exclusion criteria

• Claustrophobia or other mental disorders making MRI imaging unbearable for the patient
• Cardiac pacemakers, metal implants splinters or other contraindications for MRI
• More than 1 Human leukocyte antigen (HLA) allele or antigen mismatch between donor and recipient
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study
• Patients who are not likely to follow the trial protocol (lack of willingness to cooperate)

Trial design

134 participants in 1 patient group

Patients with MDS and AML prior to allogeneic SCT

Treatment:

Other: No intervention and study treatment