Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT00110058
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00110058
Study Brief:
Protocol Section:
NCT00110058