Clinical trial · Interventional
A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts | — | UNRESOLVED | — |
| Mixed Myelodysplastic/Myeloproliferative Disease | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Donor lymphocytes | Other | — | UNRESOLVED |
| Tapering of immune suppression | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention in MRD positive patients
- description
- Azacitidine and / or Donor lymphocytes or tapering of immune suppression
- interventionNames
- Drug: Azacitidine
- Other: Donor lymphocytes
- Other: Tapering of immune suppression
Primary outcomes (1)
- measure
- Clinical event defined as relapse or death within 1 year from first MRD+ sample
- timeFrame
- Within 1 year from first MRD+ sample
Secondary outcomes (5)
- measure
- Number of MRD+ patients achieving MRD negativity
- timeFrame
- From MRD positivity until 2y after transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available