Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
NCT ID: NCT00416598
Last Updated: 2019-02-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
546 participants
INTERVENTIONAL
2006-11-15
2016-12-01
Brief Summary
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Detailed Description
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I. To determine the efficacy, feasibility, and toxicities when one year of maintenance therapy with decitabine is given to patients \< 60 years with untreated acute myeloid leukemia (AML) who achieve and maintain first complete remission (CR) following an established induction and intensification regimen.
II. To determine the 1-year disease free survival rate for AML patients in first CR treated with maintenance decitabine.
SECONDARY OBJECTIVES:
I. To measure biologic response to decitabine in evaluable patients with fusion genes to determine eradication of minimal residual disease.
II. To measure surrogates for deoxyribonucleic acid (DNA) demethylation including downregulation of DNA methyltransferase 1 (DNMT1) and induction of fetal hemoglobin.
III. To examine the significance of gene re expression following ex vivo decitabine exposure in primary AML cells taken at the time of diagnosis on clinical outcome and on gene expression at the time of relapse after in vivo decitabine exposure.
IV. To continue to evaluate the effectiveness of a cytogenetically risk-adapted approach for consolidation therapy for patients with core binding factor (CBF) or non-CBF AML.
V. To continue the investigation begun in Cancer and Leukemia Group B (CALGB) 19808 aimed at correlation of the rate of relapse and toxicity with intravenous (IV) busulfan pharmacokinetics when busulfan and etoposide are used as the preparative regimen for autologous stem cell transplantation for AML patients in first CR.
VI. To correlate outcome measures such as complete response (CR), disease-free survival (DFS), event-free survival (EFS), and overall survival (OS), with pretreatment characteristics such as age, sex, race, blood counts, morphology, immunophenotype, cytogenetics, and molecular features of AML.
OUTLINE:
REMISSION INDUCTION THERAPY: Patients receive cytarabine IV over 168 hours on days 1-7 and daunorubicin hydrochloride IV over 5-10 minutes and etoposide IV over 2 hours on days 1-3. Patients undergo bone marrow biopsy on day 14. Patients with residual leukemia proceed to second remission induction therapy. Patients achieving complete remission (CR) proceed to intensification therapy.
SECOND REMISSION INDUCTION THERAPY: Patients receive cytarabine IV over 120 hours on days 1-5 and daunorubicin hydrochloride IV and etoposide IV over 2 hours on days 1 and 2. Patients undergo bone marrow biopsy on day 42. Patients with residual leukemia are removed from the study. Patients achieving CR proceed to intensification therapy.
INTENSIFICATION THERAPY: Patients are stratified and receive intensification therapy according to cytogenetic findings (favorable cytogenetics \[t(8;21)(q22q22), inv(16)(p13;q22), or t(16;16)(p13;q22) by cytogenetic and/or molecular analysis\] vs unfavorable cytogenetics \[all other cytogenetic findings, including normal cytogenetics\]).
FAVORABLE CYTOGENETICS: Within 2-4 weeks after achieving CR, patients receive high-dose cytarabine IV over 3 hours twice daily on days 1, 3, and 5.
Treatment repeats every 28 days for up to 3 courses.
UNFAVORABLE CYTOGENETICS: Peripheral blood stem cell (PBSC) mobilization: Within 2-4 weeks after achieving CR, patients receive etoposide IV over 96 hours and high-dose cytarabine IV over 2 hours twice daily on days 1-4 and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 14 and continuing until blood counts recover. Patients then proceed to transplantation.
PBSC OR BONE MARROW TRANSPLANTATION: Patients receive busulfan IV over 2 hours 4 times daily on days -7 to -4 and etoposide IV over 4 hours on day -3. Patients undergo autologous PBSC or bone marrow transplantation on day 0 and receive G-CSF SC once daily beginning on day 0 and continuing until blood counts recover.
UNFAVORABLE CYTOGENETICS AND UNABLE TO UNDERGO PBSC TRANSPLANTATION: Within 2-4 weeks after achieving CR, patients receive etoposide, high-dose cytarabine, and G-CSF as in unfavorable cytogenetics (PBSC mobilization) followed by 2 courses of high-dose cytarabine as in favorable genetics.
MAINTENANCE THERAPY: Within 60-90 days after completion of intensification therapy, patients receive decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
After completion of study treatment, patients are followed up every 2 months for 1 year, every 6 months for 2 years, and then yearly for 2 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (chemotherapy, PBSC or bone marrow transplantation)
See Detailed Description.
Autologous Bone Marrow Transplantation
Undergo autologous bone marrow transplantation
Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSC transplantation
Busulfan
Given IV
Cytarabine
Given IV
Daunorubicin Hydrochloride
Given IV
Decitabine
Given IV
Etoposide
Given IV
Filgrastim
Given SC
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Interventions
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Autologous Bone Marrow Transplantation
Undergo autologous bone marrow transplantation
Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSC transplantation
Busulfan
Given IV
Cytarabine
Given IV
Daunorubicin Hydrochloride
Given IV
Decitabine
Given IV
Etoposide
Given IV
Filgrastim
Given SC
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior 5-azacitidine or decitabine therapy
* No prior treatment for leukemia or myelodysplastic syndrome with four permissible exceptions:
* Emergency leukapheresis
* Emergency treatment for hyperleukocytosis with hydroxyurea
* Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
* Growth factor/cytokine support
15 Years
59 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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William Blum
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
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UCSF Medical Center-Mount Zion
San Francisco, California, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Florida Hospital Orlando
Orlando, Florida, United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States
University of Illinois
Chicago, Illinois, 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
Eastern Maine Medical Center
Bangor, Maine, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Union Hospital of Cecil County
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
Commonwealth Hematology Oncology PC-Worcester
Worcester, Massachusetts, United States
Veterans Administration
Columbia, Missouri, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Great Plains Health Callahan Cancer Center
North Platte, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Cheshire Medical Center-Dartmouth-Hitchcock Keene
Keene, New Hampshire, 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
State University of New York Upstate Medical University
Syracuse, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, 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
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Miriam Hospital
Providence, Rhode Island, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont College of Medicine
Burlington, Vermont, United States
Countries
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References
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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.
Yin J, LaPlant B, Uy GL, Marcucci G, Blum W, Larson RA, Stone RM, Mandrekar SJ. Evaluation of event-free survival as a robust end point in untreated acute myeloid leukemia (Alliance A151614). Blood Adv. 2019 Jun 11;3(11):1714-1721. doi: 10.1182/bloodadvances.2018026112.
Blum W, Sanford BL, Klisovic R, DeAngelo DJ, Uy G, Powell BL, Stock W, Baer MR, Kolitz JE, Wang ES, Hoke E, Mrozek K, Kohlschmidt J, Bloomfield CD, Geyer S, Marcucci G, Stone RM, Larson RA; Alliance for Clinical Trials in Oncology. Maintenance therapy with decitabine in younger adults with acute myeloid leukemia in first remission: a phase 2 Cancer and Leukemia Group B Study (CALGB 10503). Leukemia. 2017 Jan;31(1):34-39. doi: 10.1038/leu.2016.252. Epub 2016 Sep 13.
Other Identifiers
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NCI-2009-00444
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000521603
Identifier Type: -
Identifier Source: secondary_id
CALGB 10503
Identifier Type: OTHER
Identifier Source: secondary_id
CALGB-10503
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00444
Identifier Type: -
Identifier Source: org_study_id
NCT01647074
Identifier Type: -
Identifier Source: nct_alias
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