Status:
COMPLETED
Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Adult Acute Megakaryoblastic Leukemia (M7)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial is studying two different schedules of alvocidib to compare how well they work when given together with cytarabine and mitoxantrone in treating patients with newly diagn...
Detailed Description
PRIMARY OBJECTIVES: I. To compare the efficacy of two different schedules (bolus vs "hybrid bolus-infusion") of alvocidib followed by cytarabine and mitoxantrone hydrochloride in patients with newly ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Pathologically confirmed newly diagnosed acute myeloid leukemia (AML) meeting the following criteria:
- Subtypes M0, M1, M2, M4-7
- No acute promyelocytic leukemia (M3)
- At least 50 years of age OR \>= 18 years of age with \>= 1 of the following poor-risk disease features:
- Antecedent hematologic disorder, including myelodysplastic syndromes (MDS)-related AML or prior myeloproliferative disorder (MPD)
- Treatment-related AML, AML with trilineage dysplasia
- Myeloid sarcoma, myeloid proliferations related to Down Syndrome, or blastic plasmacytoid dendritic cell neoplasm
- AML with trilineage dysplasia
- AML with adverse cytogenetics (defined as -5/-5q; -7/-7q; abnormal 3q, 9q, 11q, 20q, 21q, or 17p; t\[6;9\]; t\[9;22\]; trisomy 8; trisomy 13, complex karyotypes \[\>= 3 unrelated abnormalities\]),
- No hyperleukocytosis with \>= 50,000 blasts/uL (leukapheresis or hydroxyurea allowed for cytoreduction immediately prior to the first dose of alvocidib)
- No active CNS leukemia
- ECOG performance status 0-2
- Serum creatinine =\< 2.0 mg/dL
- ALT/AST =\< 5 times upper limit of normal
- Bilirubin =\< 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- No active uncontrolled infection
- Infection that is under active treatment allowed provided it is controlled with antibiotics
- No other life-threatening illness
- No mental deficits and/or psychiatric history that would preclude giving informed consent or following study requirements
- At least 24 hours since prior leukapheresis or hydroxyurea for cytoreduction
- Prior non-cytotoxic therapies (e.g., thalidomide or lenalidomide, interferon, cytokines, low-dose 5-azacytidine, or low-dose cytoxan) for MDS or MPD allowed
- Prior chemotherapy or bone marrow/stem cell transplantation for non-AML malignancy allowed
- No prior alvocidib
- No other concurrent chemotherapy, radiotherapy, or immunotherapy
- No other concurrent investigational or commercially-available antitumor therapies for AML
- LVEF \>= 45%
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00795002
Start Date
November 1 2008
End Date
September 1 2012
Last Update
August 7 2018
Active Locations (2)
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1
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
2
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109