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Clinical Trial NCT07493538 for AML, MDS, Acute Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndromes is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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 Phase 2 132

Not yet recruiting
Clinical Trial NCT07493538 is designed to study Treatment for AML, MDS, Acute Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndromes. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 August 2026 until the study accrues 132 participants. Led by Masonic Cancer Center, University of Minnesota, this study is expected to complete by 1 March 2035. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
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.
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

Conditions
AMLMDSAcute LeukemiaAcute Myeloid LeukemiaMyelodysplastic Syndromes
Other Study IDs
  • 2025LS162
NCT ID Number
NCT07493538
Start Date (Actual)
2026-08
Last Update Posted
2026-03-25
Completion Date (Estimated)
2035-03
Enrollment (Estimated)
132
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalArm 1
subjects treated with Treosulfan and Fludarabine preparative regimen with TBI for AML and MDS patients followed by a related or unrelated donor stem cell infusion utilizing PTCy, tacrolimus and MMF as GVHD prophylaxis.
Treosulfan
12 g/m2 administered intravenously over 2 hours on days -4, -3, and -2.
Fludarabine
Fludarabine will be administered intravenously over 1 hour, every 24 hours on days -6 to -2. The daily dose of fludarabine will be determined by model-based dosing utilizing Bayesian methodology .
Total Body Irradiation
TBI 200 cGy will be administered as a single treatment on day -1 per current institutional guidelines.
Tacrolimus
Tacrolimus may be initiated on day +5 either PO or IV gtt , with a goal trough level of 5-10mg/mL and avoiding higher levels for the first two weeks post-transplant, as recent evidence demonstrated increased adverse events for levels over 10 mg/mL.
Mycophenolate Mofetil
All patients begin mycophenolate mofetil (MMF) day +5 through day +35 if no acute GVHD or 7 days after engraftment, whichever is later.
Cyclophosphamid
Cyclophosphamide 40 mg/kg will be given as an IV infusion over 1-2 hours (depending on volume) on Days +3 post-transplant (between 60 and 72 hours after stem cell infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide).
Stem Cell Infusion
Given on day 0.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall Survival
Evaluate rates of overall survival at 100 days after transplant.
Day 100
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Transplant Related Mortality
● Estimate transplant related mortality (TRM) at 100 days and 1 year with this conditioning and GVHD prophylaxis combination
Day 100 and 1 year
Overall Survival
Estimate overall survival at 1 and 2 years
1 and 2 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
2 Years
Eligible Sexes
All
  • 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

  • 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
Masonic Cancer Center, University of Minnesota logoMasonic Cancer Center, University of Minnesota
Study Central Contact
Contact: Christopher Graham, MD, 612-625-3051, [email protected]
No location data.