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NCT Number: NCT05788679

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

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.

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Key information

Conditions

Myelodysplastic Syndromes Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Mixed Myelodysplastic/Myeloproliferative Disease Myeloproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Hematology, Karolinska University Hospital

Stockholm, Sweden

Location status: Recruiting

Location contact

Andreas Björklund

PRINCIPAL_INVESTIGATOR

Magnus Tobiasson, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azacitidine

Drug

Azacitidine

Donor lymphocytes

Other

Donor lymphocytes in patients without immune suppression

Tapering of immune suppression

Other

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

Primary outcomes

  1. Clinical event defined as relapse or death within 1 year from first MRD+ sample

    Time frame: Within 1 year from first MRD+ sample

Secondary outcomes

  1. Number of MRD+ patients achieving MRD negativity

    Time frame: From MRD positivity until 2y after transplantation

  2. Incidence and severity of graft-versus host disease

    Time frame: From transplantation until 2y after transplantation

  3. Safety, adverse events reporting

    Time frame: After start of Azacitidine until 30 days after last azacitidine injection

  4. Relapse-free survival

    Time frame: From transplantation until 2y after transplantation

  5. Overall survival

    Time frame: From transplantation until 2y after transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Magnus Tobiasson, PhD

CONTACT

[email protected]

0046858580000

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Nordic MDS Group

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 29, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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