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

Phase 2

Recruiting

• Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts; Mixed Myelodysplastic/Myeloproliferative Disease
• Interventions: Drug: Azacitidine; Other: Donor lymphocytes; Other: Tapering of immune suppression

• Registration Number: NCT05788679
• Lead Sponsor: Karolinska University Hospital

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 available

Study Timeline

• Study Start: 2022-11-22
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-03-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention in MRD positive patients	Donor lymphocytes	Azacitidine and / or Donor lymphocytes or tapering of immune suppression
Intervention in MRD positive patients	Tapering of immune suppression	Azacitidine and / or Donor lymphocytes or tapering of immune suppression
Intervention in MRD positive patients	Azacitidine	Azacitidine and / or Donor lymphocytes or tapering of immune suppression

Primary Outcome Measures

Name	Time	Method
Clinical event defined as relapse or death within 1 year from first MRD+ sample	Within 1 year from first MRD+ sample

Secondary Outcome Measures

Name	Time	Method
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
Number of MRD+ patients achieving MRD negativity	From MRD positivity until 2y after transplantation

Trial Locations

Locations (1)

Department of Hematology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden