A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Leukemia or Lymphoma
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.
Eligibility
- Age range
- 18–74 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Malignant conditions or other life-threatening disorders correctable by transplant for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as: 1. AML in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16). 2. Secondary AML in 1st remission 3. AML in 1st relapse or 2nd remission 4. ALL/CLL in patient remission clinical or molecular features indicating a high risk for relapse; or ALL/CLL 2nd remission 5. CML failing to respond to or not tolerat…
Interventions
- RadiationTotal Body Irradiation (TBI)
Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of \< 15 cGy/minute.
- DrugThiotepa
Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).
- DrugCyclophosphamide
Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m\^2 x 5 if cyclophosphamide is contraindicated
- DrugBusulfan
Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics
- DrugMelphalan
Melphalan: 70 mg/m\^2/day x 2
- DrugFludarabine
Fludarabine: 25 mg/m\^2/day x 5
Location
- Baptist Health South Florida/Miami Cancer InstituteMiami, Florida