Total Body Irradiation with Cyclphosphamide Or Etoposide As Preparative Therapy For Autologous And Allogeneic Stem Cell Transplantation: Standard Care Treatment Protocol

Protocol Number: RMBMT-06

Major Objectives

• Cyclophosphamide 60mg/kg IV over 2 hours on Day –6 and Day –5
• Total Body Irradiation at 1.5 Gy BID on Days –3 through Day 0, for a total of 12.0 Gy.
• Transplant on Day 0

• Total Body Irradiation at 1.5 Gy BID on Days –7 through –4 for a total of 12.0 Gy.
• Etoposide 60mg/kg IV over 4 hours on Day –3.
• Transplant on Day 0

Patient Selection

Inclusion Criteria:

1. Patients with the following diagnoses are candidates for treatment with cyclophosphamide or etoposide plus TBI.
   • Acute myeloid leukemia
   • Acute lymphocytic leukemia
   • Chronic myeloid leukemia
   • Chronic lymphocytic leukemia
   • Non-Hodgkin Lymphoma
   • Hodgkin Lymphoma
   • Lymphobalstic lymphoma
   • Multiple Myeloma
2. Candidates for treatment must also meet the following criteria:
   1. Karnofsky performace status ≥ 80%
   2. Lung diffusion capacity ≥ 60% of predicted (correctd for hemoglobin)
   3. Left ventricular ejection fraction ≥ 50% as measured by multigated blood pool study (MUGA scan) or echocardiogram. Patients with ejection fraction between 40-50% must be cleared by a cardiologist after appropriate studies are performed.
   4. Creatinine clearance ≥ 60ml/minute (calculated or by 24 hour urine)
   5. Total serum bilirubin ≤ 2 x upper limit of normal
   6. AST and ALT < 2 x upper limit of normal.
   7. Previously cryopreserved autologous peripheral blood or marrow stem cells or a consenting adult donor (related or unrelated) who is suitably matched for HLA.
   8. Competent to give informed consent.

Exclusion Criteria:

1. Uncontrolled infection or comorbidities that would preclude transplantation.
2. Female patient who are pregnant and/or who do not practice adequate contraception.
3. Patients who are HIV positive.
4. Lack of mental competence to give informed consent.
5. Inability to pay for treatment.