NCT05788679

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
7mo left

Started Nov 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Nov 2022Dec 2026

Study Start

First participant enrolled

November 22, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

4 years

First QC Date

January 27, 2023

Last Update Submit

December 4, 2023

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

    Within 1 year from first MRD+ sample

Secondary Outcomes (5)

  • Number of MRD+ patients achieving MRD negativity

    From MRD positivity until 2y after transplantation

  • Incidence and severity of graft-versus host disease

    From transplantation until 2y after transplantation

  • Safety, adverse events reporting

    After start of Azacitidine until 30 days after last azacitidine injection

  • Relapse-free survival

    From transplantation until 2y after transplantation

  • Overall survival

    From transplantation until 2y after transplantation

Study Arms (1)

Intervention in MRD positive patients

EXPERIMENTAL

Azacitidine and / or Donor lymphocytes or tapering of immune suppression

Drug: AzacitidineOther: Donor lymphocytesOther: Tapering of immune suppression

Interventions

AzacitidineDRUG

Azacitidine

Intervention in MRD positive patients
Donor lymphocytesOTHER

Donor lymphocytes in patients without immune suppression

Intervention in MRD positive patients
Tapering of immune suppressionOTHER

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

Intervention in MRD positive patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, Karolinska University Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Myelodysplastic SyndromesMyeloproliferative Disorders

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Magnus Tobiasson, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magnus Tobiasson, PhD

CONTACT

0046858580000magnus.tobiasson@ki.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating investigator

Study Record Dates

First Submitted

January 27, 2023

First Posted

March 29, 2023

Study Start

November 22, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)