Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05788679

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

Led by Karolinska University Hospital · Updated on 2023-12-05

200

Participants Needed

1

Research Sites

210 weeks

Total Duration

On this page

Sponsors

K

Karolinska University Hospital

Lead Sponsor

N

Nordic MDS Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Age 18 years or older
  • Eligible for stem cell transplantation
  • Diagnosed with MDS, mixed myelodysplastic/myeloproliferative syndrome, or AML with myelodysplasia-related dysplasia and 20-29% marrow blasts
  • Female participants of childbearing potential must have a negative pregnancy test within 2 weeks before joining the study
Not Eligible

You will not qualify if you...

  • No detectable genetic abnormality found in screening or diagnostic genetic testing
  • Uncontrolled hypertension, heart, liver, kidney, or other serious medical or psychiatric conditions
  • Mental inability, reluctance, or language difficulties preventing understanding of the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Hematology, Karolinska University Hospital

Stockholm, Sweden

Actively Recruiting

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Research Team

M

Magnus Tobiasson, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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