RecruitingPhase 2NCT05788679

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


Sponsor

Karolinska University Hospital

Enrollment

200 participants

Start Date

Nov 22, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a highly sensitive blood test — called MRD (minimal residual disease) testing — to personalize treatment decisions after stem cell transplantation in patients with certain blood cancers, including myelodysplastic syndromes (MDS). MRD tests can detect tiny amounts of cancer remaining in the body that normal tests miss. **You may be eligible if...** - You are 18 or older - You are eligible for a stem cell transplant - You have been diagnosed with MDS, mixed myelodysplastic/myeloproliferative syndrome, or AML with related changes and 20–29% blasts in the bone marrow - A traceable genetic abnormality has been identified in your cancer cells **You may NOT be eligible if...** - No identifiable genetic abnormality was found in your cancer cells (needed for MRD tracking) - You have uncontrolled high blood pressure, heart, liver, or kidney problems - You have psychiatric conditions or a language barrier that makes it difficult to understand what study participation involves Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine

Azacitidine

OTHERDonor lymphocytes

Donor lymphocytes in patients without immune suppression

OTHERTapering of immune suppression

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


Locations(1)

Department of Hematology, Karolinska University Hospital

Stockholm, Sweden

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NCT05788679


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