NCT07493538RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 16 Apr 2026

Brief summary (registry, in English)

This is a Phase II study following subjects proceeding with Treosulfan (36g/m2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg/kg, tacrolimus and MMF for GVHD prophylaxis.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 132 (estimated)
First submitted: 20 Mar 2026
Start date: 10 Apr 2026
Primary completion date: Mar 2030
Lead sponsor: Masonic Cancer Center, University of Minnesota
Diseases: Myelodysplastic syndromes, Acute myeloid leukemia, Childhood cancers
NCT number: NCT07493538

What you commit to

Study type: Interventional · Phase 2
Planned participants: 132
From 10 Apr 2026 to the primary completion date, Mar 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

Less than 3 months since prior myeloablative transplant

Other illness

Evidence of untreated/uncontrolled HIV infection
Untreated active serious infection
Active CNS malignancy

Lab values

CML in blast crisis not in a complete remission by abnormal blast count.

Other

Pregnant or breastfeeding

Who the study is looking for

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

Age in the registry: 2 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Masonic Cancer Center at University of Minnesota Coordinator of this site? Confirm its status	Minneapolis	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.