Myelodysplastic Syndromes, Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts, Mixed Myelodysplastic/Myeloproliferative Disease
Conditions
Brief summary
The goal of this interventional study is to evaluate if pre-emptive intervention using Azacitidine and / or donor lymphocytes or tapering of immune suppression in measurable residual disease (MRD) positive subjects can prevent clinical relapse. Participants will undergo MRD surveillance and be subjected to intervention in case of MRD positivity. Results will be compared with NMDSG14B, part one, in which MRD was analyzed in included patients without recieving intervention.
Interventions
DRUGAzacitidine
Azacitidine
OTHERDonor lymphocytes
Donor lymphocytes in patients without immune suppression
OTHERTapering of immune suppression
Tapering of immune suppression in patients who are on immune suppressive drugs
Sponsors
Nordic MDS Group
Karolinska University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Signed informed consent * Age ≥ 18 years * Subjects eligible for SCT * Subjects having the disease MDS, mixed myelodysplastic/myeloproliferative syndrome or AML with myelodysplasia related dysplasia and 20-29% marrow blasts * All female subjects of childbearing potential have to have negative pregnancy test within 2 weeks prior to inclusion to the study
Exclusion criteria
* No traceable genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis * Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders * Mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical event defined as relapse or death within 1 year from first MRD+ sample | Within 1 year from first MRD+ sample |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | From transplantation until 2y after transplantation |
| Number of MRD+ patients achieving MRD negativity | From MRD positivity until 2y after transplantation |
| Incidence and severity of graft-versus host disease | From transplantation until 2y after transplantation |
| Safety, adverse events reporting | After start of Azacitidine until 30 days after last azacitidine injection |
| Relapse-free survival | From transplantation until 2y after transplantation |
Countries
Sweden
Contacts
Primary ContactMagnus Tobiasson, PhD
Outcome results
None listed