A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
Recruiting
Phase 2
Interventional Study
Myelodysplastic Syndromes
Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts
Mixed Myelodysplastic/Myeloproliferative Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Karolinska University Hospital · Other
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About This Trial
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…
Trial Locations
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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 t…
Contacts