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 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT00023920
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Philadelphia chromosome-positive blastic phase chronic myelogenous leukemia (CML), defined by 1 of the following:
* At least 30% blasts in peripheral blood and/or bone marrow
* Presence of extramedullary disease
* Performance status - Zubrod 0-2
* At least 8 weeks
* No prior coagulopathies
* Bilirubin no greater than 1.5 mg/dL
* INR less than 2
* PTT no greater than 60 seconds
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No nephrotic syndrome
* No uncontrolled hypertension
* No New York Heart Association class II-IV heart disease
* No prior thrombotic events
* LVEF ≥ 50%
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No more than 2 prior chemotherapy regimens (no more than 1 regimen containing cytarabine) for CML in blast crisis
* Prior hydroxyurea allowed
* Prior imatinib mesylate allowed
* At least 10 days since prior anticoagulants
* No concurrent anticoagulants
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00023920
Study Brief:
Protocol Section:
NCT00023920