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Lead
OHSU Knight Cancer Institute
With
National Cancer Institute (NCI)
OBJECTIVES:
Primary
* To assess safety and toxicity of the addition of busulfan added to an established fludarabine and low-dose total-body irradiation (TBI) conditioning regimen for non-myeloablative allogeneic transplantation in patients with hematologic malignancies. (Phase I)
* To assess the non-relapse mortality 1-year after conditioning with busulfan and fludarabine/TBI in patients with hematologic malignancies at moderate to high risk for graft rejection and/or relapse of underlying disease. (Phase II)
Secondary
* To assess overall survival 1-year survival. (Phase II)
* To assess the incidence of graft rejection. (Phase II)
* To assess the incidence of grade II-IV acute graft-vs-host disease (GVHD) and chronic extensive GVHD. (Phase II)
* To assess rates of disease progression and/or relapse-related mortality. (Phase II)
* To determine non-hematologic grade III-IV organ specific toxicity. (Phase II)
OUTLINE:
* Nonmyeloablative-conditioning regimen: Patients receive busulfan IV on day -5 and fludarabine IV over 30 minutes on days -4 to -2. Patients undergo total body irradiation on day 0.
* Allogeneic peripheral blood stem cell transplantation (PBSC): Patients undergo donor PBSC infusion on day 0.
* Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper to day 180. Patients with a related stem cell donor receive oral mycophenolate mofetil twice daily on days 0-28. Patients with an unrelated stem cell donor receive oral mycophenolate mofetil 3 times daily on days 0-28 followed by a taper twice daily to day 56. Patients with evidence of relapse or persistent disease may also receive up to 3 donor lymphocyte infusions.
PROJECTED ACCRUAL: A total of 225 patients will be accrued for this study; 25 patients accrued into the Phase I and 200 patients into Phase II.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Diagnosis of a hematologic malignancy of 1 of the following high-risk types:
* Acute lymphoblastic leukemia
* Acute myeloid leukemia
* Chronic myelogenous leukemia
* Chronic lymphocytic leukemia
* Myelodysplastic syndromes
* Myeloproliferative disorder
* Multiple myeloma
* Plasma cell dyscrasias
* Non-Hodgkin lymphoma
* Hodgkin disease
PATIENT CHARACTERISTICS:
Performance status
Karnofsky 50-100%
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
No liver failure
No cirrhosis with evidence of portal hypertension
No alcoholic hepatitis
No esophageal varices
No chronic hepatitis
No other liver disease
Renal
Not specified
Cardiovascular
Left Ventricular Ejection Fraction (LVEF) \> 35%
No symptomatic coronary artery disease or cardiac failure requiring therapy
Pulmonary
Diffusing capacity of lung for carbon monoxide (DLCO) \> 30%
Total lung capacity \> 30%
Forced expiratory volume in 1 second (FEV\_1) \> 30%
No supplementary continuous oxygen
Other
HIV negative
No active nonhematologic malignancy except localized skin cancer
No overt organ dysfunction
PRIOR CONCURRENT THERAPY:
Not specified
Clareo Health | Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer