NCT07896928Not yet recruitingPhase 2
Study of Allogeneic Stem Cell Transplant in Myelodysplastic Syndrome Following Conditioning With Fludarabine and Total Body Irradiation 800 cGy
IIT2026-01-PAQUETTE-MDSBMT: A Phase 2 Study of Allogeneic Stem Cell Transplant in Myelodysplastic Syndrome Following Conditioning With Fludarabine and Total Body Irradiation 800 cGy
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 20 Oct 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Ronald Paquette
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT07896928
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 1 Dec 2026 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with hypomethylating agent
- Prior autologous or allogeneic stem cell transplant
Who the study is looking for
- MDS diagnosis and:
- Very low, low, or low-intermediate risk by IPSS-M. This can be determined using the online calculator: https://mds-risk-model.com/. Must be relapsed, refractory or ineligible (due to serum erythropoietin level \>500 U/L) for erythropoiesis stimulating agent (ESA). Prior luspatercept or imetelstat is permitted. Transfusion-dependent requiring \>4 units packed red blood cells (PRBCs) over an 8 week period during the 16 weeks before enrollment. or
- TP53 mutation/deletion with combined VAF \< 50%
- Meets standard criteria for allogeneic stem cell transplant
- Patient and related Donor (if applicable) must sign the Informed Consent Form for the study. If donor is unrelated, donor does not sign Informed Consent Form and this will not affect recipient study eligibility
- Patient is deemed suitable to receive Flu/TBI 800 conditioning regimen as standard of care transplant.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.