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Clinical Trials in Sweden / NCT05788679
Recruiting Phase 2

A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS

NCT05788679 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska University Hospital
Phase
Phase 2
Started
2022-11-22
Last updated
2023-12-05

Condition(s) studied

Myelodysplastic SyndromesAcute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% BlastsMixed Myelodysplastic/Myeloproliferative Disease

Investigational drug(s) / intervention(s)

Azacitidine →Donor lymphocytesTapering of immune suppression

Azacitidine: Azacitidine

Donor lymphocytes: Donor lymphocytes in patients without immune suppression

Tapering of immune suppression: Tapering of immune suppression in patients who are on immune suppressive drugs

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Hematology, Karolinska University Hospital Stockholm Sweden Recruiting

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Other trials for the same condition

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve Active, not recruiting
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions Recruiting
Combining Active and Passive DNA Hypomethylation Recruiting
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05788679 on ClinicalTrials.gov ↗ ← All trials in Sweden