Actively Recruiting
Allo HSCT Using RIC and PTCy for Hematological Diseases
Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-07-01
56
Participants Needed
1
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.
CONDITIONS
Official Title
Allo HSCT Using RIC and PTCy for Hematological Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 0 to 75 years with Karnofsky score 60 70% (16 years or older) or Lansky score 60 50 (under 16 years).
- Have a 5/6 or 6/6 related donor, or a 7-8/8 HLA allele matched unrelated donor, or a haplotype matched related donor with at least 5/10 match.
- Acute leukemias must be in remission with 64 5% blasts and no minimal residual disease by flow cytometry, FISH, or cytogenetics.
- Specific remission criteria for AML, ALL, biphenotypic leukemias, chronic myelogenous leukemia, plasma cell leukemia, myelodysplastic syndromes, lymphomas, and other specified hematologic diseases.
- Adequate organ function: liver enzymes 64 5x upper limit of normal, bilirubin 64 2.5 mg/dL except Gilbert's syndrome or hemolysis.
- Renal function with normal creatinine (adults) or creatinine clearance 60 40 mL/min (children).
- Cardiac function with no decompensated heart failure, no uncontrolled arrhythmia, and ejection fraction 60 40%.
- Pulmonary function with DLCO, FEV1, FVC 60 40% predicted, no oxygen requirement.
- HIV infection allowed if viral load undetectable and managed by Infectious Disease specialist.
- Agree to use adequate birth control if sexually active and of childbearing potential.
- Voluntary written consent provided.
You will not qualify if you...
- Pregnant or breastfeeding females.
- Untreated active infections.
- Active central nervous system malignancy.
- CML in blast crisis.
- Intermediate or high grade NHL, mantle cell NHL, or Hodgkin disease progressing on salvage therapy.
- Less than 3 months since prior myeloablative transplant.
- Evidence of progressive disease by imaging or biopsy, except persistent PET activity without CT progression.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
M
Mark Juckett
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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