Status:
COMPLETED
Fludarabine and Radiation Therapy in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Phase or Accelerated Phase Chronic Myelogenous Leukemia
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the pa...
Detailed Description
OBJECTIVES: Primary * Determine the disease-free survival rate in patients with chronic or accelerated phase chronic myelogenous leukemia that failed or inadequately responded to prior imatinib mesy...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting 1 of the following criteria:
- Chronic phase
- Ph+ by cytogenetics or fluorescent in situ hybridization (FISH) assay
- Accelerated phase, meeting any of the following criteria:
- More than 10% but \< 30% myeloblasts and promyelocytes in marrow or peripheral blood
- Any additional clonal cytogenetic abnormalities
- Increasing splenomegaly
- Extramedullary tumor
- WBC, platelet count, or hematocrit perturbations not controlled by therapy with hydroxyurea, interferon, or imatinib mesylate
- Persistent unexplained fever or bone pain
- Less than 5% blasts in the marrow at time of transplantation
- Not eligible for OR refused conventional myeloablative allogeneic stem cell transplantation
- Failed OR suboptimal response to prior imatinib mesylate, as defined by 1 of the following:
- Absence of complete hematologic response after \> 3 months of treatment with imatinib mesylate
- Absence of cytogenetic response, as defined by 1 of the following:
- Absence of any cytogenetic response (\< 95% Ph+ or BCR/ABL+ cells by cytogenetic or FISH analysis, respectively) after 6 months of treatment with imatinib mesylate
- Absence of major cytogenetic response (\< 35% Ph+ or BCR/ABL+ cells by cytogenetic or FISH analysis, respectively) after 1 year of treatment with imatinib mesylate
- Absence of complete cytogenetic response (no Ph+ cells by cytogenetic analysis OR BCR/ABL+ cells within normal limits by FISH analysis) after 18 months of treatment with imatinib mesylate
- Hematologic evidence of disease progression
- Cytogenetic evidence of disease progression
- Increase in Ph+ cells or BCR/ABL+ cells by \> 20% with at least 1 month between sequential testing
- Molecular evidence of disease progression
- More than 10-fold increase in BCR/ABL mRNA levels by quantitative polymerase chain reaction (Q-PCR) with at least 1 month between 2 sequential tests
- Experienced adverse events during treatment with imatinib mesylate that precluded further administration of the drug
- No CNS disease refractory to intrathecal chemotherapy
- HLA identical related donor available
- Phenotypically matched at HLA-A, -B, -C, DRQ1, and DBQ1
- No presence of circulating leukemic blasts by standard pathology
- PATIENT CHARACTERISTICS:
- Age
- Any age
- Performance status
- Karnofsky 70-100% OR
- Lansky 70-100%
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- Hepatic
- No fulminant liver failure
- No cirrhosis of the liver with evidence of portal hypertension or bridging fibrosis
- No alcoholic hepatitis
- No esophageal varices
- No history of bleeding esophageal varices
- No hepatic encephalopathy
- No uncorrectable hepatic synthetic dysfunction evidenced by prolongation of PT
- No ascites related to portal hypertension
- No bacterial or fungal liver abscess
- No biliary obstruction
- No chronic viral hepatitis AND bilirubin \> 3 mg/dL
- No symptomatic biliary disease
- Renal
- Renal failure allowed
- Cardiovascular
- No symptomatic coronary artery disease
- Ejection fraction ≥ 35%
- No other cardiac failure requiring therapy
- No poorly controlled hypertension (blood pressure ≥ 150/90 mm Hg) on standard medication
- Pulmonary
- DLCO ≥ 30%
- Total lung capacity ≥ 30%
- FEV\_1 ≥ 30%
- No requirement for continuous supplementary oxygen
- No fungal pneumonia with radiological progression after treatment with amphotericin or mold-active azoles for \> 1 month
- Other
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for 12 months after completion of study treatment
- HIV negative
- No other disease that severely limits life expectancy
- No other active malignancy except localized nonmelanoma skin cancer
- No nonhematologic malignancy within the past 5 years that is currently in complete remission and has a \> 20% risk of disease recurrence except for nonmelanoma skin cancer
- No systemic uncontrolled infection
- No active bacterial or fungal infection unresponsive to medical therapy
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- At least 48 hours since prior imatinib mesylate
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00110058
Start Date
February 1 2005
End Date
July 1 2006
Last Update
November 17 2011
Active Locations (3)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
2
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
3
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024