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/Rocky-Mountain-Blood-and-Marrow-Transplant-Program-Busulfan-and-Cyclophosphamide-Followed-By-Hematopoietic-Stem-Cell-Transplantation-36.html

Rocky Mountain Blood and Marrow Transplant Program Busulfan and Cyclophosphamide Followed By Hematopoietic Stem Cell Transplantation:

Protocol Number: RMBMT –01


Major Objectives

Conditioning Regimen
  • Busulfan 0.8mg/kg/QID IV for 4 days (Days –7 through –4)
  • Cyclophosphamide 60mg/kg IV daily for 2 days (days –3 and –2)
  • Transplant Day 0


Supportive Care
  • Dilantin is used to prevent seizures which may be induced by the high dose busulfan.
  • 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 hematological malignancy who are deemed candidates to undergo autologous or allogeneic hematopoietic stem cell transplantation. Allogeneic transplants may be from a related or unrelated donor. If a mismatched donor is identified, the degree of match will be discussed at Pipeline Meeting for Rocky Mountain Blood and Marrow Transplant Program.
  2. Patients treated on this treatment guideline will be presented at the Pipeline Meeting for Rocky Mountain Blood and Marrow Transplant Program to determine that IV Bu/Cy is appropriate treatment for their disease and stage.
  3. Patients at least 16 years of age.
  4. FEV1/FVC ≥ 50%
  5. DLCO (corrected for alveolar volume and anemia) ≥ 50% of the predicted value.
  6. LVEF ≥ 45% by MUGA or echocardiogram.
  7. Creatinine ≤ 2 or estimate creatinine clearance >40cc/min unless the elevated Cr is felt to be due to the underlying disease.
  8. Serum alkaline phosphatase, total bilirubin, AST or ALT: ≤ 2 time the upper limit of normal.
  9. Patient must have functioning central line catheter.

Exclusion Criteria:

  1. Active uncontrolled infection that would be a contraindication to safe use of high-dose therapy.
  2. Positive serology for Hepatitis B surface antigen.
  3. Positive serology for human immunodeficiency virus (HIV).
  4. Presence of other comorbid illnesses with an estimated median life expectancy of < 2 years.
  5. Pregnancy
  6. Inability to give voluntary informed consent.
  7. Demonstrated lack of compliance with prior medical care.
  8. Unwilling to use contraceptive methods for at least 15 months after starting treatment.
  9. Allergy to Busulfan or Cyclophosphamide.