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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT00015834
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of chronic myelogenous leukemia in myeloid blast crisis
* At least 30% blasts in bone marrow
* Philadelphia chromosome positive by cytogenetic analysis
* bcr/abl translocation by fluorescent in situ hybridization
* 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
* Performance status - ECOG 0-2
* See Disease Characteristics
* Bilirubin less than 3 times upper limit of normal (ULN)
* AST and ALT less than 3 times ULN
* Creatinine less than 2 times ULN
* No New York Heart Association class III or IV heart disease
* 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
* See Disease Characteristics
* No prior allogeneic bone marrow or peripheral blood stem cell transplantation
* At least 48 hours since prior interferon alfa
* At least 24 hours since prior hydroxyurea
* At least 6 weeks since prior busulfan
* No other prior chemotherapy for blast crisis (except hydroxyurea)
* Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed
* At least 4 weeks since prior investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00015834
Study Brief:
Protocol Section:
NCT00015834