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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT00077493
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (including lymphoblastic lymphoma, Burkitt's lymphoma, and large cell lymphoma)
* Not amenable to available curative therapies
* Relapsed or refractory disease after at least 1 standard chemotherapy and 1 salvage regimen
* CD22 positive according to at least 1 of the following criteria:
* More than 15% CD22-positive malignant cells by immunohistochemistry
* More than 30% CD22-positive malignant cells by fluorescent-activated cell sorter analysis
* Measurable or evaluable disease
* Prior CNS involvement allowed provided there is no current evidence of CNS malignancy
* No CNS leukemia or lymphoma as manifested by any of the following:
* Cerebrospinal fluid (CSF) WBC ≥ 5/mm\^3 and confirmation of CSF blasts
* Cranial neuropathies secondary to underlying malignancy
* Radiologically detected CNS lymphoma
* No isolated testicular ALL
* Ineligible for or refused hematopoietic stem cell transplantation OR has disease activity that prohibits the time required to identify a suitable stem cell donor
PATIENT CHARACTERISTICS:
Age
* 6 months to 24 years
Performance status
* ECOG 0-3 (12 to 24 years of age)
* Lansky 40-100% (under 12 years of age)
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
* Absolute neutrophil count \> 1,000/mm\^3 \*
* Platelet count \> 50,000/mm\^3 \* NOTE: \*Non-leukemic patients only
Hepatic
* Bilirubin ≤ 2.0 mg/dL
* AST and ALT ≤ 5 times upper limit of normal
* No active hepatitis B or C infection
Renal
* Creatinine normal for age OR
* Creatinine clearance ≥ 60 mL/min
Immunologic
* No serum neutralization of more than 75% of the activity of 1 µg/mL of study drug
* HIV negative
Other
* 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 other significant organ dysfunction that would preclude study participation
* No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* At least 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa)
* Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT) allowed
* More than 100 days since prior allogeneic HSCT
Chemotherapy
* See Disease Characteristics
* At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy
* Concurrent corticosteroids allowed provided there has been no increase in the dose 1 week prior to and after study entry
* Steroid taper allowed
Radiotherapy
* At least 3 weeks since prior radiotherapy
* Allowed in the past 3 weeks provided the volume of the bone marrow treated is \< 10% AND the patients has measurable disease outside of the radiation port
Surgery
* Not specified
Other
* Recovered from prior therapy
* At least 30 days since prior investigational drugs
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
24 Years
Study:
NCT00077493
Study Brief:
Protocol Section:
NCT00077493