1800 Williams St., Suite 200 • Denver, CO 80218
Phone 303-388-4876 • Fax 303-336-2193 • Toll Free 1-800-891-7622

URL http://www.rockymountainbmt.com/clinical_trials/Total-Body-Irradiation-with-Cyclphosphamide-Or-Etoposide-As-Preparative-Therapy-For-Autologous-And-Allogeneic-Stem-Cell-Transplantation-Standard-Care-Treatment-Protocol-38.html

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

Conditioning Regimen
  • 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

OR
  • 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


Supportive Care
Mesna is used to prevent hemorrhagic cystitis which may be induced by cyclophosphamide.

Supportive care will follow Standard Operating Procedures and Institutional Guidelines.

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:

Patients will be ineligible for treatment for any of the following reasons:
  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.