Back to resultsA Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
Primary Purpose
Myelodysplastic Syndromes, Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts, Mixed Myelodysplastic/Myeloproliferative Disease
Status
Recruiting
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Azacitidine
Donor lymphocytes
Tapering of immune suppression
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes
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 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
Sites / Locations
- Department of Hematology, Karolinska University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention in MRD positive patients
Arm Description
Azacitidine and / or Donor lymphocytes or tapering of immune suppression
Outcomes
Primary Outcome Measures
Clinical event defined as relapse or death within 1 year from first MRD+ sample
Secondary Outcome Measures
Number of MRD+ patients achieving MRD negativity
Incidence and severity of graft-versus host disease
Safety, adverse events reporting
Relapse-free survival
Overall survival
Full Information
NCT ID
NCT05788679
First Posted
January 27, 2023
Last Updated
March 27, 2023
Sponsor
Karolinska University Hospital
Collaborators
Nordic MDS Group
1. Study Identification
Unique Protocol Identification Number
NCT05788679
Brief Title
A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Nordic MDS Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts, Mixed Myelodysplastic/Myeloproliferative Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention in MRD positive patients
Arm Type
Experimental
Arm Description
Azacitidine and / or Donor lymphocytes or tapering of immune suppression
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Azacitidine
Intervention Type
Other
Intervention Name(s)
Donor lymphocytes
Intervention Description
Donor lymphocytes in patients without immune suppression
Intervention Type
Other
Intervention Name(s)
Tapering of immune suppression
Intervention Description
Tapering of immune suppression in patients who are on immune suppressive drugs
Primary Outcome Measure Information:
Title
Clinical event defined as relapse or death within 1 year from first MRD+ sample
Time Frame
Within 1 year from first MRD+ sample
Secondary Outcome Measure Information:
Title
Number of MRD+ patients achieving MRD negativity
Time Frame
From MRD positivity until 2y after transplantation
Title
Incidence and severity of graft-versus host disease
Time Frame
From transplantation until 2y after transplantation
Title
Safety, adverse events reporting
Time Frame
After start of Azacitidine until 30 days after last azacitidine injection
Title
Relapse-free survival
Time Frame
From transplantation until 2y after transplantation
Title
Overall survival
Time Frame
From transplantation until 2y after transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magnus Tobiasson, PhD
Phone
0046858580000
Email
magnus.tobiasson@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Tobiasson, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology, Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magnus Tobiasson, PhD
First Name & Middle Initial & Last Name & Degree
Andreas Björklund
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
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