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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT00015860
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* One of the following diagnoses:
* Chronic myelogenous leukemia in lymphoid blast crisis
* Acute lymphoblastic leukemia (ALL) that is in first relapse or failed induction
* No more than 1 prior course of induction chemotherapy
* Philadelphia chromosome-positive (Ph+) by cytogenetic analysis OR bcr/abl translocation by fluorescent in situ hybridization
* At least 30% blasts in bone marrow
* Ineligible for or refused allogeneic stem cell transplantation
* Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin less than 3 times upper limit of normal (ULN)
* ALT and AST less than 3 times ULN
Renal:
* Creatinine less than 2 times ULN
Cardiovascular:
* No New York Heart Association class III or IV cardiac disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* No prior allogeneic bone marrow or peripheral blood stem cell transplantation
* At least 48 hours since prior interferon alfa
Chemotherapy:
* See Disease Characteristics
* At least 24 hours since prior hydroxyurea
* At least 6 weeks since prior busulfan
* Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No prior therapy for blast crisis except hydroxyurea
* No prior salvage or reinduction therapy for Ph+ ALL
* At least 4 weeks since other prior investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00015860
Study Brief:
Protocol Section:
NCT00015860