Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Therapy-Related Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT01420926

Run by

National Cancer Institute (NCI)

People needed

165

Starts

2011-11-16

Expected to finish

2021-04-01

Last updated by the study team

2023-02-28

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and CBF molecular screening results from CALGB 20202
• No prior treatment for AML except:
• Emergency leukapheresis
• Emergency treatment for hyperleukocytosis with hydroxyurea
• Cranial radiotherapy (RT) for central nervous system (CNS) leukostasis (one dose only)
• Growth factor/cytokine support
• AML patients with an antecedent hematologic disorder (AHD) or myelodysplastic syndrome (MDS) are eligible for this trial provided that they have not received treatment for their AHD or MDS with cytotoxic chemotherapy (e.g., cytarabine, daunorubicin, etc.), decitabine, or bortezomib; patients may have been previously treated with azacitidine if their last dose was >= 90 days prior to starting 11002
• AML patients with therapy-related myeloid neoplasms (t-MN) are eligible if they have not received radiation therapy or chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for > 6 months

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• AdventHealth Orlando — Orlando, Florida, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne, Indiana, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Harold Alfond Center for Cancer Care — Augusta, Maine, United States
• Eastern Maine Medical Center — Bangor, Maine, United States
• Christiana Care - Union Hospital — Elkton, Maryland, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Bronson Battle Creek — Battle Creek, Michigan, United States
• Spectrum Health Big Rapids Hospital — Big Rapids, Michigan, United States
• Cancer Research Consortium of West Michigan NCORP — Grand Rapids, Michigan, United States
• Mercy Health Saint Mary's — Grand Rapids, Michigan, United States
• Spectrum Health at Butterworth Campus — Grand Rapids, Michigan, United States
• Mercy Health Mercy Campus — Muskegon, Michigan, United States
• Spectrum Health Reed City Hospital — Reed City, Michigan, United States
• Munson Medical Center — Traverse City, Michigan, United States
• University of Missouri - Ellis Fischel — Columbia, Missouri, United States
• Palo Alto Medical Foundation-Camino Division — Mountain View, California, United States

Full record on ClinicalTrials.gov

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