A Study Using Subject-specific MRD to Adopt Treatment Aft... | NCT05788679

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

NCT05788679

Sponsor

Karolinska University Hospital

Status

Recruiting

Last Update Posted

Dec 5, 2023Actual

Enrollment

200Estimated

Phase

Phase 2

Conditions

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

Interventions

Azacitidine
Donor lymphocytes
Tapering of immune suppression

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2022Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Jan 27, 2023

First Submission Date that Met QC Criteria

Mar 27, 2023

First Posted Date

Mar 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2023

Last Update Posted Date

Dec 5, 2023Actual

Name	Class
Nordic MDS Group	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention in MRD positive patients	Experimental	Azacitidine and / or Donor lymphocytes or tapering of immune suppression	Drug: Azacitidine Other: Donor lymphocytes Other: Tapering of immune suppression

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azacitidine	Drug	Azacitidine	Intervention in MRD positive patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical event defined as relapse or death within 1 year from first MRD+ sample		Within 1 year from first MRD+ sample

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Magnus Tobiasson, PhD	Contact	0046858580000		magnus.tobiasson@ki.se

Overall Officials

Name	Affiliation	Role
Magnus Tobiasson, PhD	Karolinska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hematology, Karolinska University Hospital	Recruiting	Stockholm			Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D009190	Myelodysplastic Syndromes
D009196	Myeloproliferative Disorders

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D001374	Azacitidine

Ancestor Terms

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides