MedDataX Logo

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

NCT ID: NCT05788679

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-22

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention in MRD positive patients

Azacitidine and / or Donor lymphocytes or tapering of immune suppression

Group Type EXPERIMENTAL

Azacitidine

Intervention Type DRUG

Azacitidine

Donor lymphocytes

Intervention Type OTHER

Donor lymphocytes in patients without immune suppression

Tapering of immune suppression

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Azacitidine

Azacitidine

Intervention Type DRUG

Donor lymphocytes

Donor lymphocytes in patients without immune suppression

Intervention Type OTHER

Tapering of immune suppression

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nordic MDS Group

NETWORK

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Magnus Tobiasson

Coordinating investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Magnus Tobiasson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Hematology, Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Magnus Tobiasson, PhD

Role: CONTACT

Phone: 0046858580000

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Magnus Tobiasson, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NMDSG14B, part 2

Identifier Type: -

Identifier Source: org_study_id