Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia (NCT01420926) | Clinical Trial Compass
CompletedPhase 2
Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia
United States165 participantsStarted 2011-11-16
Plain-language summary
This randomized phase II trial studies how well giving decitabine with or without bortezomib works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells,by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether decitabine works better when given with or without bortezomib in treating acute myeloid leukemia.
Who can participate
Age range60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Unequivocal pathologic diagnosis of AML (\>= 20% blasts in the bone marrow based on World Health Organization \[WHO\] criteria) EXCLUDING:
* Acute promyelocytic leukemia t(15;17)(q22;q12); PML-RARA
* Acute myeloid leukemia with t(8;21)(q22;q22); RUNX1-RUNXT1 as determined by the Ohio State University (OSU) Molecular Reference Laboratory, per Cancer and Leukemia Group B (CALGB) 20202; however patients who (1) are \>= 75 years; and/or (2) have an ejection fraction of \< 40%; and/or (3) have a performance status of \> 2, may be registered to CALGB 20202 and registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and core-binding factor (CBF) molecular screening results from CALGB 20202
* Acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); CBFB-MYH11 as determined by the OSU Molecular Reference Laboratory, per CALGB 20202; however patients who (1) are \>= 75 years; and/or (2) have an ejection fraction of \< 40%; and/or (3) have a performance status of \> 2, may be registered to CALGB 20202 and registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and CBF molecular screening results from CALGB 20202
* Absence of FLT3 mutation (ITD or point mutation) determined by the OSU Molecular Reference Laboratory, per CALGB 20202; however patients who (1) are \>= 75 years; and/or (2) have an ejection fraction of \< 40%; and/or (3) have a performance status of \> 2, may be registered to CALGB 20202 and reg…