Status:
COMPLETED
3-AP and Fludarabine in Treating Patients With Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia, or Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Accelerated Phase Chronic Myelogenous Leukemia
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving 3-AP together with fludarabine works in treating patients with myeloproliferative disorders (MPD), chronic myelomonocytic leukemia (CMML), or accelerate...
Detailed Description
OBJECTIVES: I. Determine the efficacy of 3-AP (Triapine®) followed by fludarabine phosphate in patients with myeloproliferative disorders or chronic myelomonocytic leukemia in aggressive phase or tra...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00381550
Start Date
August 1 2006
End Date
March 1 2011
Last Update
January 6 2015
Active Locations (1)
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1
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287