Reduced-intensity donor stem cell transplant with treosulfan/fludarabine and post-transplant cyclophosphamide for leukemia and MDS
Official title: MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases
Run by Masonic Cancer Center, University of Minnesota · NCT07493538 · Data updated 2026-11-12
This trial tests a lower-intensity donor stem cell transplant using treosulfan plus fludarabine with post-transplant cyclophosphamide to try to reduce toxicity and prevent graft-versus-host disease in people aged 2–75 with acute leukemias or myelodysplastic syndromes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 75 Years |
| Sex | All |
| Enrollment | 132 (estimated) |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | April 10, 2026 |
| Main results expected | March 2030 |
| Study ends | March 2035 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07493538 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 2–75 with AML, acute leukemia, or MDS who have an appropriate related, unrelated, or haploidentical donor and adequate liver, kidney, cardiac, and pulmonary function without uncontrolled infection.
✕Probably not a fit
Patients with decompensated liver failure, severe cardiac or pulmonary dysfunction, active uncontrolled infections or CNS malignancy, untreated HIV, pregnancy or breastfeeding, very recent myeloablative transplant, or CML in blast crisis are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase II protocol gives a treosulfan (36 g/m2) plus fludarabine preparative regimen followed by allogeneic stem cell infusion from related, unrelated, or haploidentical family donors. Post-transplant graft-versus-host disease prophylaxis uses cyclophosphamide 40 mg/kg on specified post-transplant days along with tacrolimus and mycophenolate mofetil. The study includes patients age 2–75 with adequate organ function and no uncontrolled infections or active CNS malignancy. Outcomes will include engraftment, transplant-related toxicity, and incidence of acute and chronic GVHD.
Why it matters
Potential benefit: If successful, the regimen could provide effective donor transplants with lower conditioning toxicity and less graft-versus-host disease, making transplant an option for older or frailer patients.
How similar studies have gone: Similar reduced-intensity treosulfan/fludarabine regimens have shown promising engraftment and lower toxicity in prior reports, and post-transplant cyclophosphamide is an established approach to reduce graft-versus-host disease.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 2-75 years of age * ≤7 5 years of age: Karnofsky score ≥ 70% (≥ 16 years) or Lansky play score ≥ 50 (\< 16 years) with appropriate organ criteria as below (in other inclusion criteria) * 5/6 or 6/6 related donor, OR a 5-8/8 HLA-A, B, C, DRB1 allele match unrelated donor, OR a haplotype (at least 5/10) related donor * adequate liver (no decompensated liver failure, Child Pugh A, AST/ALT \<5X ULN) and renal function (creatinine \<2.0) * absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40% * DLCO FEV1, FVC ≥ 40% predicted, and absence of O2 requirement Exclusion Criteria: * Pregnant or breastfeeding * Evidence of untreated/uncontrolled HIV infection * Untreated active serious infection * Active CNS malignancy * CML in blast crisis not in a complete remission by abnormal blast count. * Less than 3 months since prior myeloablative transplant
Where it's running
-
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Study coordinator: Christopher Graham, MD
- Email: grah0329@umn.edu
- Phone: 612-625-3051
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.