A Phase 2 interventional study of Allogeneic Stem Cell Transplant in MDS, Myelodysplastic Syndrome MDS and Myelodysplastic Syndrome (MDS), sponsored by Ronald Paquette. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Ronald Paquette · Phase 2, Interventional, and Treatment
Among 1,363 studies in Myelodysplastic Syndromes with a site in United States — 176 open to participants now, 280 under way, 17 of them phase 3. Myelodysplastic Syndromes · United States.
Among the 1,363 studies in Myelodysplastic Syndromes with a site in United States, this one is the 809th largest by planned enrollment of the 1,189 interventional ones, is one of 31 that started in 2026, is one of 520 in phase 2, reaches primary completion later than 253 of the 274 other live ones, and was the 1,363rd registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →176 of the 1,363 studies in Myelodysplastic Syndromes with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 262 Myelodysplastic Syndromes studies recruiting now, 165 (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: all sexes · no healthy volunteers.
The full table on the hub →1,363 studies; the count open now beside each. This study's row is marked.
First in 1984; this study’s year is marked. 31 started in 2026.
Median enrollment 35 across the 1,189 interventional studies, 145 across the 94 observational. Of the 1,000 that completed or were terminated, 465 (47%) have results posted.
338 of 1,363 have an industry lead sponsor. The 10 most frequent:
Ronald Paquette is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Ronald Paquette has 1 study filed under Myelodysplastic Syndromes — fewer than ten, so there is no comparison to draw.
92 of the studies in Myelodysplastic Syndromes with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04401748Phase 3AbbVieStudy Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome | 2027-07 |
| NCT04256317Phase 3Taiho Oncology, Inc.A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) | 2027-11-01 |
| 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 |
| NCT03121014University of Illinois at ChicagoStudy of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes | 2026-11 |
| NCT05362773MacroGenicsA Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies | 2026-11 |
Among the 1,363 studies in Myelodysplastic Syndromes with a site in United States, from their registry updates:
This is a single center phase II study of allogeneic stem cell transplantation in MDS who are unlikely to benefit from conventional therapy. Patients will undergo standard allogeneic stem cell transplant protocol following standard Flu/TBI 800 conditioning, PBSC transplant, and GVHD prophylaxis with PTCy and tacrolimus.
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.
MDS diagnosis and:
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Allogeneic Stem Cell Transplant
Standard RIC with fludarabine TBI-800 cGy. GVHD prophylaxis with cyclophosphamide on days +3 and +4, with dose established by ongoing GeriBMT trial, and tacrolimus/mycophenolate beginning day +5
Overall Survival (OS)
Evaluate the 1-year OS of two groups of MDS patients following allogeneic stem cell transplantation: transfusion-dependent lower-risk patients and patients with TP53 mutations/deletions with VAF \<50%.
Time frame: 1 year following transplantation
Time to neutrophil and platelet engraftment
Measure the time to neutrophil and platelet engraftment
Time frame: 30 days after PTCy Administration
Rate of Acute Graft-versus-host disease (GVHD)
Evaluate the rate of acute GVHD by 100 days
Time frame: 100 days after PTCy Administration
Severity of Acute Graft-versus-host disease (GVHD)
Evaluate the severity of acute GVHD by 100 days
Time frame: 100 days after PTCy Administration
Rate of Acute Graft-versus-host disease (GVHD)
Evaluate the rate of acute GVHD by 1 year
Time frame: 1 year after PTCy Administration
Severity of Acute Graft-versus-host disease (GVHD)
Evaluate the severity of acute GVHD by 1 year
Time frame: 1 year after PTCy Administration
Non-relapse mortality
Assess rate of non-relapse mortality at 30 days and 1 year
Time frame: 30 days after PTCy Administration, 1 year after PTCy Administration
Relapse Rate
Determine the relapse rate at 1 year
Time frame: 1 year after PTCy Administration
GVHD-free relapse-free survival (GRFS)
Calculate the rate of GVHD-free relapse-free survival (GRFS) at 1 year
Time frame: 1 year after PTCy Administration
Transfusion-independence
Determine the frequency of transfusion-independence at 1 year
Time frame: 1 year after PTCy Administration
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2030, 48 months later.
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 48 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Ronald Paquette