NCT07493538 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
| NCT ID | NCT07493538 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Condition | AML |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2030-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 132 participants in total. It began in 2026-04-10 with a primary completion date of 2030-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07493538 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 75 Years, studying AML. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07493538 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07493538 currently recruiting?
Yes, NCT07493538 is actively recruiting participants. Contact the research team at grah0329@umn.edu for enrollment information.
Where is the NCT07493538 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT07493538 clinical trial?
NCT07493538 is sponsored by Masonic Cancer Center, University of Minnesota. The trial plans to enroll 132 participants.