Myelodysplastic SyndromesPhase 2NCT05788679
A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
A Phase 2 study testing Azacitidine, Donor lymphocytes and Tapering of immune suppression in people with Myelodysplastic Syndromes and Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts, Mixed Myelodysplastic/Myeloproliferative Disease
- What is being tested?
- Azacitidine, Donor lymphocytes and Tapering of immune suppression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 22 Nov 2022to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Department of Hematology, Karolinska University Hospital
Stockholm
Magnus Tobiasson, PhD
Andreas Björklund
About this study
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
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.
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts, Mixed Myelodysplastic/Myeloproliferative Disease
- Being tested
- Azacitidine, Donor lymphocytes, Tapering of immune suppression
- Medical subject headings
- Myelodysplastic Syndromes, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Azacitidine
Donor lymphocytesOther
Donor lymphocytes in patients without immune suppression
Tapering of immune suppressionOther
Tapering of immune suppression in patients who are on immune suppressive drugs
| Study group | Role | What they receive |
|---|---|---|
| Intervention in MRD positive patients | Experimental | Azacitidine and / or Donor lymphocytes or tapering of immune suppression Receives: Drug: Azacitidine; Other: Donor lymphocytes; Other: Tapering of immune suppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical event defined as relapse or death within 1 year from first MRD+ sample
Measured: Within 1 year from first MRD+ sample
Secondary outcomes (5)
Number of MRD+ patients achieving MRD negativity
Measured: From MRD positivity until 2y after transplantation
Incidence and severity of graft-versus host disease
Measured: From transplantation until 2y after transplantation
Safety, adverse events reporting
Measured: After start of Azacitidine until 30 days after last azacitidine injection
Relapse-free survival
Measured: From transplantation until 2y after transplantation
Overall survival
Measured: From transplantation until 2y after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start22 Nov 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic MDS Group
- Responsible party
- Principal investigator, Magnus Tobiasson, Karolinska University Hospital
- Investigators
- Magnus Tobiasson, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788679
- Sponsor's protocol ID
- NMDSG14B, part 2
- Status last verified
- Dec 2023
- First submitted
- 27 Jan 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05788679
- Acronym / sponsor ID
- NMDSG14B, part 2
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts, Mixed Myelodysplastic/Myeloproliferative Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Nordic MDS Group
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention in MRD positive patients | Experimental | Drug: Azacitidine, Other: Donor lymphocytes, Other: Tapering of immune suppressionAzacitidine and / or Donor lymphocytes or tapering of immune suppression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacitidineAzacitidine | Drug | Intervention in MRD positive patients |
| Donor lymphocytesDonor lymphocytes in patients without immune suppression | Other | Intervention in MRD positive patients |
| Tapering of immune suppressionTapering of immune suppression in patients who are on immune suppressive drugs | Other | Intervention in MRD positive patients |
Primary outcome
Clinical event defined as relapse or death within 1 year from first MRD+ sample
Time frame: Within 1 year from first MRD+ sample
5 secondary outcomes
Number of MRD+ patients achieving MRD negativity
Time frame: From MRD positivity until 2y after transplantation
Incidence and severity of graft-versus host disease
Time frame: From transplantation until 2y after transplantation
Safety, adverse events reporting
Time frame: After start of Azacitidine until 30 days after last azacitidine injection
Relapse-free survival
Time frame: From transplantation until 2y after transplantation
Overall survival
Time frame: From transplantation until 2y after transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magnus Tobiasson, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine, Donor lymphocytes and Tapering of immune suppression in people with Myelodysplastic Syndromes and Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus Tobiasson, PhD (0046858580000, magnus.tobiasson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical event defined as relapse or death within 1 year from first MRD+ sample (time frame: Within 1 year from first MRD+ sample). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.