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

NCT05788679 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-12-05

No results posted yet for this 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.

Conditions

  • Myelodysplastic Syndromes
  • Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts
  • Mixed Myelodysplastic/Myeloproliferative Disease

Interventions

DRUG

Azacitidine

Azacitidine

OTHER

Donor lymphocytes

Donor lymphocytes in patients without immune suppression

OTHER

Tapering of immune suppression

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

Sponsors & Collaborators

  • Nordic MDS Group

    collaborator NETWORK

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Magnus Tobiasson, PhD · Karolinska University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05788679 on ClinicalTrials.gov