NCT05788679RecruitingPhase 2
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 · Last updated 5 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 27 Jan 2023
- Start date
- 22 Nov 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Karolinska University Hospital
- NCT number
- NCT05788679
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 22 Nov 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders
Other
- No traceable genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis
- Mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Hematology, Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.