A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Leukemia or Lymphoma

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

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

Location