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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT00022451
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed acute lymphoblastic leukemia, acute nonlymphoblastic leukemia, juvenile myelomonocytic leukemia (JMML), or chronic myelogenous leukemia (CML) in blast crisis
* Refractory to standard curative therapy
* Acute promyelocytic leukemia refractory to tretinoin and arsenic trioxide
* Philadelphia chromosome-positive CML refractory to imatinib mesylate
* Greater than 25% blasts in bone marrow (M3 bone marrow) except for patients with JMML
* Active extramedullary disease allowed
* No active leptomeningeal leukemia
PATIENT CHARACTERISTICS:
Age:
* 21 and under
Performance status:
* Karnofsky 50-100% (over 10 years of age)
* Lansky 50-100% (10 years of age and under)
Life expectancy:
* Not specified
Hematopoietic:
* Not required to be normal
Hepatic:
* Bilirubin normal
* SGPT and SGOT normal
* No significant hepatic dysfunction
* No grade 3 or 4 liver function test results within the past month
Renal:
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
* No significant renal dysfunction
Cardiovascular:
* No significant cardiac dysfunction
Pulmonary:
* No significant pulmonary dysfunction
Neurologic:
* No history of grand mal seizures grade 3 or greater except febrile seizures
* No persistent sensory or motor neuropathy greater than grade 2
Other:
* No clinically significant unrelated systemic illness
* No serious infection
* No organ dysfunction that would preclude study participation
* No requirement for total parenteral nutrition
* No known allergy to azoles (e.g., clotrimazole, fluconazole, ketoconazole, voriconazole)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 1 week since prior colony-stimulating factor therapy (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) except epoetin alfa
* At least 3 months since prior myeloablative therapy followed by bone marrow or stem cell transplantation
* No concurrent immunotherapy
* No concurrent GM-CSF or interleukin-11
Chemotherapy:
* At least 2 weeks since prior chemotherapy
* No concurrent intrathecal chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* At least 1 week since prior corticosteroids
* No concurrent corticosteroids (except for acute allergic reaction)
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* Recovered from nonhematologic toxicity of all prior therapy
* At least 1 week since prior retinoids
* No antacids (magnesium- or aluminum-containing formulations) within 2 hours of study drug
* No other concurrent investigational agents
* No concurrent retinoids
* No concurrent anticonvulsants
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00022451
Study Brief:
Protocol Section:
NCT00022451