Status:
COMPLETED
Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Leukemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's i...
Detailed Description
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-myeloablati...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00245037
Start Date
June 1 2005
End Date
August 1 2015
Last Update
September 27 2017
Active Locations (1)
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1
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098