A Phase 2 interventional study of Azacitidine and Donor lymphocytes in Myelodysplastic Syndromes, Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts and Mixed Myelodysplastic/Myeloproliferative Disease, sponsored by Karolinska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Karolinska University Hospital · Phase 2, Interventional, and Treatment
Among 130 studies testing azacitidine in Myelodysplastic Syndromes — 13 open to participants now, 25 under way, 3 of them phase 3. Azacitidine · Myelodysplastic Syndromes.
Among the 130 studies testing azacitidine in Myelodysplastic Syndromes, this one is the 8th largest by planned enrollment of the 126 interventional ones that give a count, is one of 4 that started in 2022, is one of 63 in phase 2, reaches primary completion later than 11 of the 24 other live ones, and was the 117th registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
Browse Myelodysplastic Syndromes studies →13 of the 130 studies testing azacitidine in Myelodysplastic Syndromes are open now, in 12 countries. Recruiting first, the newest first:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 18–70
City of Hope Medical Center · Sites in United States
Ages 18–75
Medical College of Wisconsin · Sites in United States
Ages 18+
Institut de Recherches Internationales Servier · Sites in United States, Australia, Brazil and 7 more countries
Ages 18+
Beijing 302 Hospital · Sites in China
Ages 18–70
By country, each count listing its studies:
Azacitidine: first FDA approval 2004 (VIDAZA), first EMA approval 2008. What it is approved for, and how studies give it, is on its page →
Of the 264 Myelodysplastic Syndromes studies recruiting now, 167 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
130 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 50 · Phase 2 86 · Phase 3 12 · Phase 4 3
First in 2000; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Median enrollment 38 across the 126 interventional studies. Of the 88 that completed or were terminated, 42 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
32 of 130 have an industry lead sponsor. The 10 most frequent:
Karolinska University Hospital is the lead sponsor of 279 studies on the registry; 55 are open to participants now.
Karolinska University Hospital has 1 study filed under Myelodysplastic Syndromes — fewer than ten, so there is no comparison to draw.
9 of the studies testing azacitidine in Myelodysplastic Syndromes that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06465953Phase 3Institut de Recherches Internationales ServierIvosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation | 2027-11-01 |
| NCT05788679Karolinska University HospitalA Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS | 2026-12 |
| NCT00392353National Cancer Institute (NCI)Vorinostat and Azacitidine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia | 2026-12-31 |
| NCT06502145Medical College of WisconsinIadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome | 2026-12-31 |
| NCT03862157M.D. Anderson Cancer CenterAzacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | 2027-01-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 130 studies testing azacitidine in Myelodysplastic Syndromes, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Azacitidine and / or Donor lymphocytes or tapering of immune suppression
Drug: Azacitidine · Other: Donor lymphocytes · Other: Tapering of immune suppression
Azacitidine
Donor lymphocytes in patients without immune suppression
Tapering of immune suppression in patients who are on immune suppressive drugs
Clinical event defined as relapse or death within 1 year from first MRD+ sample
Time frame: Within 1 year from first MRD+ sample
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
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Dec 2026, 49 months after the start.
Of 227 non-industry phase 2 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 116. This study's planned 49 months is below that.
Counting every sponsor, half of 279 studies reached it within 66 months; a quarter within 40 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Azacitidine
Karolinska University Hospital →