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Trial Title:
A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
NCT ID:
NCT05788679
Condition:
Myelodysplastic Syndromes
Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts
Mixed Myelodysplastic/Myeloproliferative Disease
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Azacitidine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
Azacitidine
Arm group label:
Intervention in MRD positive patients
Intervention type:
Other
Intervention name:
Donor lymphocytes
Description:
Donor lymphocytes in patients without immune suppression
Arm group label:
Intervention in MRD positive patients
Intervention type:
Other
Intervention name:
Tapering of immune suppression
Description:
Tapering of immune suppression in patients who are on immune suppressive drugs
Arm group label:
Intervention in MRD positive patients
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Hematology, Karolinska University Hospital
Address:
City:
Stockholm
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Magnus Tobiasson, PhD
Investigator:
Last name:
Andreas Björklund
Email:
Principal Investigator
Start date:
November 22, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
Karolinska University Hospital
Agency class:
Other
Collaborator:
Agency:
Nordic MDS Group
Agency class:
Other
Source:
Karolinska University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05788679
