Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission (NCT01465386) | Clinical Trial Compass
TerminatedPhase 2
Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission
Stopped: Closed early due to slow enrollment
United States6 participantsStarted 2011-11
Plain-language summary
This phase II trial studies how well bortezomib works in treating patients with high-risk acute myeloid leukemia (AML) in remission. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* All adults with first remission AML including those with prior myelodysplasia (MDS)/AML, therapy-related AML, AML with trilineage dysplasia (AML-TLD), and AML with adverse cytogenetics
* History of histopathologically documented AML that is currently in first remission with the presence of 5% or less blasts by morphology and/or flow cytometry from a bone marrow aspirate and/or biopsy obtained within 14 days of enrollment
* Patients must start therapy between 3-8 weeks after receiving their last prior therapy (either induction therapy or consolidation therapy)
* Patients may receive up to 4 courses of remission consolidation therapy (e.g., cytarabine) prior to enrollment
* Normal kidney and liver function with serum creatinine =\< 2.0 mg/dl
* Total bilirubin =\< 1.5 upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse
* Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contra…