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:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT00085150
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Non-Hodgkin's lymphoma, including the following subtypes:
* Lymphoblastic lymphoma
* Burkitt's lymphoma
* Large cell lymphoma
* Adult T-cell leukemia/lymphoma
* Cutaneous T-cell lymphoma
* Peripheral T-cell lymphoma
* Hodgkin's disease
* Acute myeloid leukemia
* Chronic myelogenous leukemia
* Acute lymphoblastic leukemia (ALL)
* More than 5% blasts in the bone marrow (i.e., M2 marrow classification)
* Acute hybrid leukemia, including the following subtypes:
* Mixed lineage leukemia
* Biphenotypic leukemia
* Undifferentiated leukemia
* CD25-positive (CD25+) disease, meeting 1 of the following criteria:
* More than 15% of malignant cells are CD25+ by immunohistochemistry with anti-CD25 antibody
* More than 30% of malignant cells from a site are CD25+ by fluorescence-activated cell sorting analysis
* Measurable or evaluable disease
* Relapsed or refractory disease after at least 1 standard chemotherapy regimen AND 1 salvage regimen
* No available alternative curative therapies
* Ineligible for or refused hematopoietic stem cell transplantation OR disease activity that prohibits the required time to identify a suitable stem cell donor
* No CNS leukemia or lymphoma, as evidenced by any of the following criteria:
* Cerebrospinal fluid (CSF) WBC \> 5/µl AND confirmation of CSF blasts
* Cranial neuropathies secondary to underlying malignancy
* CNS lymphoma detected by radiological imaging
* Prior CNS involvement with no current evidence of CNS malignancy allowed
* No isolated testicular ALL
PATIENT CHARACTERISTICS:
Age
* 6 months to 21 years
Performance status
* ECOG 0-3 (≥ 12 years of age)
* Lansky 40-100% (\< 12 years of age)
Life expectancy
* Not specified
Hematopoietic
* Pancytopenia due to disease allowed
* For patients without bone marrow involvement:
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 50,000/mm\^3 (transfusion independent)
Hepatic
* Bilirubin ≤ 2.0 mg/dL
* AST and ALT ≤ 5 times upper limit of normal
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative
Renal
* Creatinine clearance ≥ 60 mL/min OR
* Creatinine, meeting the following age-related criteria:
* ≤ 0.8 mg/dL (≤ 5 years of age)
* ≤ 1.0 mg/dL (6 to 10 years of age)
* ≤ 1.2 mg/dL (11 to 15 years of age)
* ≤ 1.5 mg/dL (\> 15 years of age)
* Calcium 2.0-2.9 mmol/L
Cardiovascular
* Ejection fraction ≥ 45% by MUGA OR
* Shortening fraction ≥ 28% by echocardiogram
Pulmonary
* Oxygen saturation ≥ 90%
Other
* Sodium 130-150 mmol/L
* Potassium 3.0-5.5 mmol/L
* Magnesium 0.5-1.23 mmol/L
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No clinically significant unrelated systemic illness that would preclude study participation
* No conditions that would preclude study compliance
* No serum that neutralizes \> 75% of the activity of 1 μg/mL of LMB-2 immunotoxin in tissue culture (due to either anti-toxin or anti-mouse immunoglobulin G antibodies)
* No active graft-vs-host disease (i.e., off immunosuppression)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior autologous bone marrow transplantation (BMT) allowed
* At least 100 days since prior allogeneic BMT
* At least 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa)
Chemotherapy
* At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) except intrathecal chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Concurrent corticosteroids allowed provided the dose has been stable for the past week and does not increase during study treatment
* Tapering or discontinuation of steroids allowed
Radiotherapy
* At least 3 weeks since prior radiotherapy unless \< 10% of marrow is irradiated and measurable disease exists outside the radiation port
Surgery
* Not specified
Other
* Recovered from all prior therapy
* At least 30 days since prior investigational agents
* Concurrent oral supplementation to maintain normal electrolyte levels allowed
* No concurrent anticoagulation therapy for disease-related conditions
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00085150
Study Brief:
Protocol Section:
NCT00085150