Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia
NCT ID: NCT01420926
Last Updated: 2023-02-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
165 participants
INTERVENTIONAL
2011-11-16
2021-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
NCT00742625
Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission
NCT01465386
Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia
NCT00666588
Azacitidine, Mitoxantrone Hydrochloride, and Etoposide in Treating Older Patients With Poor-Prognosis Acute Myeloid Leukemia
NCT01260714
Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
NCT00416598
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To determine if treatment of older acute myeloid leukemia (AML) patients with decitabine and bortezomib significantly improves the overall survival times of older AML patients compared with decitabine alone.
SECONDARY OBJECTIVES:
I. To determine the rate of complete remission (CR and CR + incomplete blood count recovery \[CRi\]) for each of the 2 treatment regimens in the proposal.
II. To determine the overall survival, progression-free survival, disease-free survival and for each of the treatment regimens on this study.
III. To determine whether ongoing treatment with these regimens prolongs overall survival even in the absence of complete remission.
IV. To describe the frequency and severity of adverse events, as well as the tolerability of each of these regimens in patients treated on this study.
V. To describe the interaction of pretreatment disease and patient characteristics including morphology, cytogenetics, molecular genetics, white blood cell (WBC) count, blood and bone marrow blast count, age, performance status and comprehensive geriatric assessment on clinical outcomes.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: REMISSION INDUCTION THERAPY: Patients receive decitabine intravenously (IV) over 1 hour once daily (QD) on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CR with CRi proceed to continuation therapy. Patients achieving CR or CR with CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM B: REMISSION INDUCTION THERAPY: Patients receive decitabine IV over 1 hour QD on days 2-11 and bortezomib subcutaneously (SC) on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CR with CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive bortezomib SC on day 1 and decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive bortezomib SC on day 1 and decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months for 2 years, every 3 months for 2 years, and then once a year for a maximum of 10 years from study entry.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A (decitabine)
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Decitabine
Given IV
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm B (decitabine and bortezomib)
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bortezomib
Given SC
Decitabine
Given IV
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bortezomib
Given SC
Decitabine
Given IV
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gail J Roboz
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
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
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Northwell Health NCORP
Lake Success, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Mount Sinai Hospital
New York, New York, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Vidant Oncology-Kinston
Kinston, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Cancer Care Associates-Norman
Norman, Oklahoma, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont and State Agricultural College
Burlington, Vermont, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Seffernick AE, Mrozek K, Nicolet D, Stone RM, Eisfeld AK, Byrd JC, Archer KJ. High-dimensional genomic feature selection with the ordered stereotype logit model. Brief Bioinform. 2022 Nov 19;23(6):bbac414. doi: 10.1093/bib/bbac414.
Ritchie EK, Klepin HD, Storrick E, Major B, Le-Rademacher J, Wadleigh M, Walker A, Larson RA, Roboz GJ. Geriatric assessment for older adults receiving less-intensive therapy for acute myeloid leukemia: report of CALGB 361101. Blood Adv. 2022 Jun 28;6(12):3812-3820. doi: 10.1182/bloodadvances.2021006872.
Roboz GJ, Mandrekar SJ, Desai P, Laumann K, Walker AR, Wang ES, Kolitz JE, Powell BL, Attar EC, Stock W, Bloomfield CD, Kohlschmidt J, Mrozek K, Hassane DC, Garraway L, Jane-Valbuena J, Baltay M, Tracy A, Marcucci G, Stone RM, Larson RA. Randomized trial of 10 days of decitabine +/- bortezomib in untreated older patients with AML: CALGB 11002 (Alliance). Blood Adv. 2018 Dec 26;2(24):3608-3617. doi: 10.1182/bloodadvances.2018023689.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2011-02987
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000709218
Identifier Type: -
Identifier Source: secondary_id
CALGB-11002
Identifier Type: OTHER
Identifier Source: secondary_id
CALGB-11002
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02987
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.