None listed
Conditions
Brief summary
The primary purpose of this study is to evaluate whether the flow cytometric residual disease (MRD) test can effectively predict relapse in patients with acute myeloid leukaemia (AML) who are undergoing an allogenic stem cell transplant (SCT). Who is it for? You may be eligible to participate in this study if you are aged over 18 years and have been diagnosed with AML for which you are scheduled to undergo SCT. Study details All participants enrolled in this trial will have a bone marrow sample taken at 1 month prior to SCT and 1, 3 and 6 months following the SCT. The MRD test will be run on all of these samples. Only the MRD results from your treating institution will be made available to your treating physician, which may be used to guide relapse-prevention therapy. This is in accordance with current standard of care. The results of the MRD tests at each timepoint will be compared to the time of any relapses in AML which occur up to 12 months following the SCT. It is hoped that this study will provide information on whether MRD can effectively predict relapse in AML following SCT, and whether it can help to guide preventative therapy prior to relapse.
Interventions
Patients with acute myeloid leukaemia (AML) who have had an allograft will be eligible for this trial. Minimal residual disease (MRD), performed by flow cytometry will be assessed at 1 month pre-allograft and 1, 3 and 6 months post-allograft. MRD is residual leukaemia that is undetectable by conventional microscopy. Our current “gold-standard” for identifying disease is based on microscopy. However, several studies have demonstrated the presence of MRD by immunological methods using a flow cyt
Patients with acute myeloid leukaemia (AML) who have had an allograft will be eligible for this trial. Minimal residual disease (MRD), performed by flow cytometry will be assessed at 1 month pre-allograft and 1, 3 and 6 months post-allograft. MRD is residual leukaemia that is undetectable by conventional microscopy. Our current “gold-standard” for identifying disease is based on microscopy. However, several studies have demonstrated the presence of MRD by immunological methods using a flow cytometer is predictive of relapse and overall survival. Flow cytometry (FCM) is a test where protein expression is tested on or within leukaemic cells. The primary endpoint is to compare, in a prospective setting, the time to morphological relapse (TTMR) between patients who are MRD+ at that time point, and those who are MRD- at that time point. The cut-off values for MRD positivity is 0.1% ie. our detection sensitivity threshold is validated to 1 in 10 000 white blood cell events. Follow-up is for 12 months. MRD testing will require a bone marrow biopsy sample. The bone marrow biopsy and MRD testing is a procedure performed routinely, irrespective of clinical trial participation. MRD testing by flow cytometry will be performed in accordance with standard procedures by the treating hospital and additionally by the Peter MacCallum Cancer Centre for the sole purpose of assessing inter-observer variability. Only the results performed by the treating hospital will be made available to the treating physician/patient in accordance with standard of care.
Sponsors
Peter MacCallum Cancer Centre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients over 18years who are scheduled for an allograft for acute myeloid leukaemia.
Exclusion criteria
Persistent morphological disease
Outcome results
None listed