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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT00006092
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following:
* Acute lymphoblastic leukemia
* Philadelphia chromosome (Bcr-abl) positive
* Refractory to initial therapy OR recurrent following 1 induction therapy regimen with or without consolidation therapy and/or bone marrow transplantation
* Blastic phase chronic myelogenous leukemia
* Philadelphia chromosome (Bcr-abl) positive
* Previously untreated OR recurrent or refractory following 1 induction therapy regimen with or without consolidation therapy including imatinib mesylate
* Must not be eligible for bone marrow transplant
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2.0 times upper limit of normal (ULN)
* AST/ALT no greater than 2 times ULN
Renal:
* Creatinine no greater than 2.0 times ULN
* Creatinine clearance greater than 70 mL/min
Cardiovascular:
* No uncontrolled angina
* No New York Heart Association class III or IV heart disease
* No second degree heart block without pacemaker
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
* HIV negative
* No uncontrolled infection or other serious concurrent illness
* No peripheral neuropathy
* No potassium less than 3.0 or greater than 5.5 mEq/L that can not be corrected OR
* No magnesium less than 1.2 or greater than 2.5 mEq/L that can not be corrected
* Electrolyte imbalances must be corrected prior to study entry
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
* At least 28 days since prior chemotherapy
* At least 24 hours since prior hydroxyurea
* No prior arsenic trioxide
* No other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for CNS leukemia
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 28 days since prior radiotherapy
* No concurrent radiotherapy including for palliation
Surgery:
* Not specified
Other:
* At least 14 days since prior imatinib mesylate
* No other concurrent investigational agents
* No concurrent amphotericin B
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006092
Study Brief:
Protocol Section:
NCT00006092