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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT00381550
Eligibility Criteria:
Criteria:
* Not pregnant or nursing
* Histopathologically confirmed diagnosis of 1 of the following:
* Myeloproliferative disorders (MPDs) in aggressive phase or transformation
* CML in accelerated phase or blast crisis
* Chronic myelomonocytic leukemia in aggressive phase (5-19% bone marrow blasts) or transformation (\> 20% bone marrow blasts)
* Myeloproliferative disorders (MPDs) in aggressive phase or transformation, including the following:
* Polycythemia vera (PV)
* Essential thrombocythemia (ET)
* Myelofibrosis with myeloid metaplasia
* Hypereosinophilic syndrome
* Atypical (Philadelphia chromosome negative) chronic myelogenous leukemia (Ph- CML)
* Patients with aggressive phase MPD (PV, ET, or Ph- CML) must meet ≥ 1 of the following criteria:
* Marrow blasts \> 5%
* Peripheral blood blasts plus progranulocytes \> 10%
* New onset or increasing myelofibrosis
* New onset or \> 25% increase in hepatomegaly or splenomegaly
* New onset constitutional symptoms (fever, weight loss, splenic pain, bone pain)
* Multilineage bone marrow failure
* Ineligible for established curative regimens, including stem cell transplantation
* ECOG performance status 0-2
* Negative pregnancy test
* Fertile patients must use effective contraception
* No chronic toxicity from prior chemotherapy \> grade 1
* No history of severe coronary artery disease
* Creatinine normal OR creatinine clearance \>= 60 mL/min
* AST and ALT =\< 2.5 times normal
* Bilirubin =\< 2.0 mg/dL unless due to leukemia, Gilbert's syndrome, or hemolysis
* No arrhythmias (other than atrial flutter or fibrillation) requiring medication
* No uncontrolled congestive heart failure
* No dyspnea at rest or with minimal exertion
* No severe pulmonary disease requiring supplemental oxygen
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to 3-AP (Triapine®) and/or fludarabine phosphate
* No other life-threatening illness
* No history of mental deficits and/or psychiatric illness that would preclude study compliance
* No more than 4 prior induction regimens (3 cytotoxic chemotherapy regimens)
* At least 3 weeks since prior myelosuppressive cytotoxic agents (6 weeks for mitomycin C or nitrosoureas) and recovered
* At least 1 week since prior nonmyelosuppressive treatment
* At least 48 hours since prior noncytotoxic agents for peripheral blood leukemic cell count control, including but not limited to the following:
* Hydroxyurea
* Imatinib mesylate
* Interferon
* Mercaptopurine
* Cyclophosphamide
* At least 2 weeks since prior and no concurrent radiotherapy to treat cancer
* At least 1 week since prior biologic therapy, including hematopoietic growth factors (e.g., epoetin alfa, darbepoetin alfa, filgrastim \[G-CSF\], sargramostim \[GM-CSF\], interleukin-3, or interleukin-11)
* No other concurrent chemotherapy to treat cancer
* No concurrent immunotherapy to treat cancer
* No known glucose-6-phosphate dehydrogenase \[G6PD) deficiency (G6PD screening required for high-risk groups (i.e., patients of African, Asian, or Mediterranean origin/ancestry)\]
* No active heart disease
* No concurrent myeloid growth factors
* No active uncontrolled infection (Infections under active treatment and controlled with antibiotics are allowed)
* No chronic hepatitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00381550
Study Brief:
Protocol Section:
NCT00381550