A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Azacitidine, Donor lymphocytes, Tapering of immune suppression.
- Who it may be relevant to
- Registry conditions: Myelodysplastic Syndromes, Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts, Mixed Myelodysplastic/Myeloproliferative Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Multicenter Single-armed Study Using Subject-specific Minimal Residual Disease Markers to Adopt Treatment After Allogeneic Stem Cell Transplantation for Subjects With Myelodysplastic Syndrome
Overview
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
- Drug Azacitidine
Azacitidine - Other Donor lymphocytes
Donor lymphocytes in patients without immune suppression - Other Tapering of immune suppression
Tapering of immune suppression in patients who are on immune suppressive drugs
Primary outcome measures
- Clinical event defined as relapse or death within 1 year from first MRD+ sample [Time frame: Within 1 year from first MRD+ sample]
Secondary outcome measures (5)
- Number of MRD+ patients achieving MRD negativity [Time frame: From MRD positivity until 2y after transplantation]
- Incidence and severity of graft-versus host disease [Time frame: From transplantation until 2y after transplantation]
- Safety, adverse events reporting [Time frame: After start of Azacitidine until 30 days after last azacitidine injection]
- Relapse-free survival [Time frame: From transplantation until 2y after transplantation]
- Overall survival [Time frame: From transplantation until 2y after transplantation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Department of Hematology, Karolinska University Hospital — Stockholm
Identifiers
NCT: NCT05788679 · NMDSG14B, part 2