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CD34+ Transplants for Leukemia and Lymphoma
Sponsor: Guenther Koehne
Summary
This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.
Official title: A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Leukemia or Lymphoma
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-06
Completion Date
2033-06
Last Updated
2026-03-03
Healthy Volunteers
No
Interventions
Total Body Irradiation (TBI)
Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of \< 15 cGy/minute.
Thiotepa
Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).
Cyclophosphamide
Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m\^2 x 5 if cyclophosphamide is contraindicated
Busulfan
Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics
Melphalan
Melphalan: 70 mg/m\^2/day x 2
Fludarabine
Fludarabine: 25 mg/m\^2/day x 5
Locations (1)
Baptist Health South Florida/Miami Cancer Institute
Miami, Florida, United States