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

Myelodysplastic Syndromes Clinical Trial

Official title:

A Phase II Multicenter Single-armed Study Using Subject-specific Minimal Residual Disease Markers to Adopt Treatment After Allogeneic Stem Cell Transplantation for Subjects With Myelodysplastic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788679
• Other study ID #: NMDSG14B, part 2
• Status: Recruiting
• Phase: Phase 2
• Start date: November 22, 2022
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: Karolinska University Hospital
• Contact: Magnus Tobiasson, PhD
• Phone: 0046858580000
• Email: magnus.tobiasson[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myeloproliferative Disorders
• Preleukemia

Intervention

Drug:
• Azacitidine
Azacitidine

Other:
• Donor lymphocytes
Donor lymphocytes in patients without immune suppression
• Tapering of immune suppression
Tapering of immune suppression in patients who are on immune suppressive drugs

Locations

Country	Name	City	State
Sweden	Department of Hematology, Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Nordic MDS Group

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical event defined as relapse or death within 1 year from first MRD+ sample		Within 1 year from first MRD+ sample
Secondary	Number of MRD+ patients achieving MRD negativity		From MRD positivity until 2y after transplantation
Secondary	Incidence and severity of graft-versus host disease		From transplantation until 2y after transplantation
Secondary	Safety, adverse events reporting		After start of Azacitidine until 30 days after last azacitidine injection
Secondary	Relapse-free survival		From transplantation until 2y after transplantation
Secondary	Overall survival		From transplantation until 2y after transplantation