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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT00004932
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Recurrent Philadelphia (Ph) chromosome-positive leukemia
* Recurrent or refractory acute lymphoblastic or myeloblastic leukemia OR
* Chronic myelogenous leukemia with resistance to interferon alfa with any of the following:
* WBC at least 20,000/mm\^3 after at least 3 months of interferon therapy
* At least 100% increase in WBC to at least 20,000/mm\^3 confirmed over 2 weeks while receiving interferon alfa
* At least 66% Ph chromosome-positive cells after 1 year of interferon therapy
* At least 30% increase in number of Ph chromosome-positive cells after an interferon-induced response while continuing interferon therapy
PATIENT CHARACTERISTICS:
Age:
* Under 22
Performance status:
* Karnofsky 50-100% if over 10 years of age OR
* Lansky 50-100% if 10 years of age and under
Life expectancy:
* At least 8 weeks
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGPT less than 3 times normal
* Albumin greater than 2 g/dL
Renal:
* Creatinine no greater than 1.5 times normal OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* If prior allogeneic stem cell transplantation, no uncontrolled graft-versus -host disease
* No seizure disorder if on anticonvulsants
* No uncontrolled infection
* No CNS toxicity greater than grade 2
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* At least 1 week since prior biologic therapy and recovered
* At least 3 months since prior stem cell transplantation (SCT)
* At least 1 week since prior growth factors
* At least 1 week since prior interferon alfa
Chemotherapy:
* Recovered from prior chemotherapy
* At least 6 weeks since prior busulfan and nitrosoureas
* At least 2 weeks since prior homoharringtonine
* At least 1 week since low-dose cytarabine
* At least 2 weeks since prior moderate-dose cytarabine
* At least 4 weeks since prior high-dose cytarabine
* At least 3 weeks since all other prior cytotoxic chemotherapies
* No prior hydroxyurea
Endocrine therapy:
* Must be on a stable dose of steroids if received prior allogeneic SCT
Radiotherapy:
* Recovered from prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months since prior craniospinal radiotherapy
* At least 6 months since prior radiotherapy to 50% or more of the pelvis
* At least 6 weeks since other prior substantial bone marrow radiotherapy
Surgery:
* Not specified
Other:
* No other concurrent investigational agents
* No concurrent anticonvulsants
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00004932
Study Brief:
Protocol Section:
NCT00004932