Trials / Recruiting
RecruitingNCT05788679
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Karolinska University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Myelodysplastic Syndromes
- Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts
- Mixed Myelodysplastic/Myeloproliferative Disease
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-11-22
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2023-03-29
- Last updated
- 2023-12-05
Locations
1 site across 1 country: Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05788679. Inclusion in this directory is not an endorsement.