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NOT YET RECRUITING
NCT05565105
PHASE2

CD34+ Transplants for Leukemia and Lymphoma

Sponsor: Guenther Koehne

View on ClinicalTrials.gov

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

RADIATION

Total Body Irradiation (TBI)

Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of \< 15 cGy/minute.

DRUG

Thiotepa

Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).

DRUG

Cyclophosphamide

Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m\^2 x 5 if cyclophosphamide is contraindicated

DRUG

Busulfan

Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics

DRUG

Melphalan

Melphalan: 70 mg/m\^2/day x 2

DRUG

Fludarabine

Fludarabine: 25 mg/m\^2/day x 5

Locations (1)

Baptist Health South Florida/Miami Cancer Institute

Miami, Florida, United States