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Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02085408
Recruitment Status : Active, not recruiting
First Posted : March 12, 2014
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Secondary Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia Drug: clofarabine Drug: daunorubicin hydrochloride Other: clinical observation Drug: cytarabine Drug: decitabine Other: laboratory biomarker analysis Procedure: quality-of-life assessment Other: questionnaire administration Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 727 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin &Amp; Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age >/= 60 Years)
Actual Study Start Date : December 28, 2010
Estimated Primary Completion Date : September 2018


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Arm I (daunorubicin hydrochloride and cytarabine)
See Detailed Description
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Other: clinical observation
Undergo clinical observation
Other Name: observation
Drug: cytarabine
Given IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Experimental: Arm II (clofarabine)
See Detailed Description
Drug: clofarabine
Given IV
Other Names:
  • CAFdA
  • Clofarex
  • Clolar
Drug: decitabine
Given IV
Other Names:
  • 5-aza-dCyd
  • 5AZA
  • DAC
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies


Outcome Measures

Primary Outcome Measures :
  1. Overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 5 years ]
    Due to the potential confounding by maintenance therapy on the induction comparison, a weighted analysis (weighted Cox regression) will be used for the primary analysis.


Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: 30 days ]
  2. Induction complete response rates [ Time Frame: Up to 5 years ]
    The induction response (CR + CRi) rates will be compared between the clofarabine arm and the standard treatment arm. At the end of the study, the 95% confidence interval on the difference in the CR + CRi rates (CR + CRi rate of standard treatment - CR + CRi rate of clofarabine) will be computed based on the normal approximation to the difference of two independent binomial proportions.

  3. Disease-free survival (DFS) [ Time Frame: Time from the second randomization to relapse or death without relapse, assessed up to 5 years ]
    The primary analysis of DFS will use a one-sided log rank test stratified on the induction therapy and on patient age and cytogenetics to determine the effect of decitabine on DFS as a maintenance therapy in comparison with observation.

  4. Overall survival [ Time Frame: Up to 5 years ]
    To evaluate the impact of consolidation with non-ablative conditioning and allogeneic hematopoietic stem cell transplantation with an HLA-identical sibling on overall survival in patients who achieve a 'morphologic leukemia-free state, a one-sided log rank test stratified on age, therapy-related AML, the presence of AHD at the time of diagnosis of AML, and the induction therapy they received will be used.

  5. Epidemiological factors, measured using the Acute Leukemia Epidemiology and Survival in ECOG (ALESE) questionnaire [ Time Frame: Baseline ]
    The proportions of obese patients and patients who had benzene exposure, ever smoked in their lifetime, took aspirin regularly, took acetaminophen regularly, ever lived in rural/farm environments, or had other exposures or lifestyle factors will be calculated separately, along with their 95% confidence intervals.

  6. Change in the Functional Assessment of Cancer Therapy (FACT)-Leukemia-specific (Leu) Trial Outcome Index (TOI) score [ Time Frame: Baseline to 30 days after beginning induction therapy ]
    Descriptive statistics will be provided and Cronbach's alpha will be calculated at each time point to assess reliability. Repeated measures analysis techniques will also be utilized to examine the treatment effect and time effect on FACT-Leu TOI score. For patients randomized to the induction treatments, the longitudinal scores collected from time of randomization, two weeks after beginning induction therapy (at the time of nadir), and at 28-30 days after beginning induction therapy, will be analyzed according to the methods described in Schluchter and Schluchter, Greene and Beck.

  7. Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score [ Time Frame: Baseline to 30 days after beginning induction therapy ]
    Descriptive statistics will be provided and Cronbach's alpha will be calculated at each time point to assess reliability. Repeated measures analysis techniques will also be utilized to examine the treatment effect and time effect on FACIT Fatigue score. For patients randomized to the induction treatments, the longitudinal scores collected from time of randomization, two weeks after beginning induction therapy (at the time of nadir), and at 28-30 days after beginning induction therapy, will be analyzed according to the methods described in Schluchter and Schluchter, Greene and Beck.


Other Outcome Measures:
  1. Epigenetic signatures, determined by expression and methylation profiling [ Time Frame: Up to 5 years ]
    The methods described in Thompson et.al will be used to identify epigenetics signatures which are different between patients who relapsed and patients who did not relapse. Signatures identified by epigenetic analysis will be correlated with DFS using a least angle regression and shrinkage (LARS)/least absolute shrinkage and selection operator (LASSO) approach for each maintenance arm.

  2. Gene expression levels [ Time Frame: Up to 5 years ]
    Genes will be filtered by examining ratios of standard deviation to the mean. Genes will be hierarchically clustered to find genes with high/low fold change/differences. Supervised analyses will be used to identify genes that are differentially expressed between patients who relapsed and patients who did not relapsed. Genes or epigenetic signatures identified by gene expression or epigenetic analysis will be correlated with DFS using LARS/LASSO approach.

  3. Predictive mutations [ Time Frame: Up to 5 years ]
    For each mutation a stratified log-rank test will be performed (using the strata at randomization) adjusted for multiple testing using resampling and the min-p method of Westfall and Young as implemented in the R package multtest. In addition tests for interaction between treatment assignment and mutational status will be performed to identify potential predictive mutations. The prognostic relevance of known mutations on overall survival and response to therapy will be assessed, and novel mutations identified in discovery studies and by other efforts will also be included.

  4. Prognostic risk groups [ Time Frame: Up to 5 years ]
    Prognostic risk groups will be identified by using recursive partitioning and logistic regression, both of which are highly suitable for binary predictors. A randomly chosen subsample of 423 (2/3 of 635) patients will be used for training these models and the remaining 212 for validation.

  5. Pgp levels [ Time Frame: Up to 5 years ]
    The possible association of response to clofarabine with Pgp will be explored using a Wilcoxon rank-sum test.

  6. CXCR4 expression levels [ Time Frame: Up to 5 years ]
    Expression intensity of CXCR4 will be divided into three groups (low, intermediate, high). The grading will be further simplified as high/intermediate vs. low. Data will be first analyzed by induction treatment arms. When data are available, logistic and Cox regression analysis, adjusted by treatment effect and prognostic factors (including cytogenetics), will be used to assess whether CXCR4 expression level is an independent predictor for response or survival.


Eligibility Criteria

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sexually active males must be strongly advised to use an accepted and effective method of contraception
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< grade 1
  • Total bilirubin =< grade 1

    • Note: If total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible
  • Patient must not have a concurrent active malignancy for which they are receiving treatment (other than myelodysplastic syndromes [MDS])
  • Patient must not have an active, uncontrolled infection
  • ADDITIONAL INDUCTION ELIGIBILITY CRITERIA:
  • Newly-diagnosed AML patients according to World Health Organization (WHO) classification who are considered candidates for intensive chemotherapy based upon examination of peripheral blood or bone marrow aspirate specimens or touch preparations of the bone marrow biopsy obtained within two weeks prior to randomization; a bone marrow aspirate is required for enrollment; however, on occasion there is discordance between percentage of myeloblasts on the differential of the peripheral blood or aspirate; the peripheral blood criteria are sufficient for diagnosis; confirmatory immunophenotyping will be performed centrally

    • NOTE: patients must be registered to E3903 (Ancillary Laboratory Protocol for the Collection of Diagnostic Material on Patients Considered for Eastern Cooperative Oncology Group (ECOG) Treatment Trials for Leukemia or Related Hematologic Disorders) and must undergo eligibility testing for the study by multiparameter flow cytometry
    • NOTE: Southwest Oncology Group (SWOG)/Cancer Trials Support Unit (CTSU) institutions: E3903 is not open at the CTSU; therefore, baseline submissions must be submitted on E2906
  • ECOG performance status (PS) 0-3 (restricted to ECOG PS 0-2 if >= 70 years of age)
  • Patients with acute promyelocytic leukemia (APL) confirmed either by the presence of t(15;17)(q22;q21) or promyelocytic leukemia (PML)/retinoic acid receptor (RAR) alpha transcripts will be excluded
  • Patients must not have blastic transformation of chronic myelogenous leukemia
  • Patients with secondary AML are eligible for enrollment onto the trial; secondary AML is defined as AML that has developed in a person with a history of antecedent blood count abnormalities, or myelodysplastic syndrome (MDS), or a myeloproliferative disorder (excluding chronic myeloid leukemia); or a history of prior chemotherapy or radiation therapy for a disease other than AML

    • NOTE: Prior therapy of MDS with decitabine, low-dose cytarabine, or azacitidine is excluded
  • Patients may not have received prior chemotherapy for AML with the exception of hydroxyurea for increased blast count or leukapheresis for leukocytosis
  • Total serum bilirubin =< 1.5 times upper limit of normal (ULN) (=< grade 1); if total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible
  • Patients with a serum creatinine > 1 are eligible if they have a calculated glomerular filtration rate (GFR) of >= 60 ml/min (i.e. class I or class II chronic kidney disease ) using the Modification of Diet in Renal Disease (MDRD) formula

    • Note: Daily creatinine and MDRD formula are only for the 1st induction cycle
  • Cardiac ejection fraction >= 45% or within institutional normal limits; a nuclear medicine gated blood pool examination is preferred; a two-dimensional (2-D) echocardiogram (ECHO) scan is acceptable if a calculated ejection fraction is obtained and follow-up measurement of the cardiac ejection fraction will also be performed by echocardiography; measurement of cardiac ejection fraction should be within two weeks prior to receiving treatment

    • NOTE: when a multi gated acquisition scan (MUGA) or echocardiogram cannot be obtained due to weekend or holiday, then patients may be enrolled provided there is no history of significant cardiovascular disease and a measurement of cardiac ejection fraction will be performed within 5 days of study enrollment
  • Patients with suspected central nervous system (CNS) involvement should undergo lumbar puncture; those with documented CNS involvement will be excluded
  • Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts (>10^9/l) from peripheral blood; this must be done via E3903

    • NOTE: SWOG/CTSU institutions: E3903 is not open at the CTSU; therefore, baseline submissions must be submitted on E2906
  • Patients who have received previous treatment for antecedent hematological disorders (AHD) with 5-azacitidine, decitabine, or low dose cytarabine will be excluded
  • Patients with known human immunodeficiency virus (HIV) infection are excluded
  • HLA typing should be performed at registration, if possible
  • Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing; this must be done via E2906

    • NOTE: SWOG/CTSU institutions: E3903 is not open at the CTSU; therefore, baseline submissions must be submitted on E2906
  • CONSOLIDATION CRITERIA:
  • NOTE: All patients achieving CR or complete remission with incomplete blood count recovery (CRi) will receive consolidation when fit
  • NOTE: Patients proceeding to transplant are allowed up to one cycle of consolidation treatment
  • Consolidation cycle 1 must commence within sixty days of the bone marrow aspirate and biopsy that confirmed the presence of a CR or CRi
  • Patients must have achieved a CR or CRi (or morphologic leukemia-free state for those patients proceeding to Arm G transplant)
  • Patients who have achieved a CR or CRi must have maintained peripheral blood evidence of a CR or CRi
  • Patients must have an ECOG performance status of 0-2
  • Patients must have resolved any serious infectious complications related to induction

    • NOTE: Patients with an HLA-matched donor and proceeding to transplant will be allowed up to one cycle of consolidation treatment
  • Any significant medical complications related to induction must have resolved
  • Patients must have a creatinine and AST =< grade 1
  • MAINTENANCE CRITERIA:
  • Maintenance should commence within 60 days of recovery of peripheral blood counts after consolidation cycle 2; patients must begin consolidation cycle 2 within 60 days of recovery to be eligible for further therapy
  • Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging bone marrow (BM) aspirate and biopsy and cytogenetic analysis
  • Patients must have an ECOG performance status of 0 -2
  • Patients must have resolved any serious infectious complications related to consolidation cycle 2
  • Any significant medical complications related to consolidation cycle 2 must have resolved
  • Total serum bilirubin =< 1.5 x ULN

    • NOTE: if total bilirubin is 2-3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible
  • Serum creatinine =< grade 1
  • The absolute neutrophil count (ANC) must be > 1000 mm^3 prior to starting every cycle of treatment with decitabine; decitabine may be delayed for up to 4 weeks between cycles (i.e. may be administered as infrequently as every (q) 8 weeks) while waiting for counts to recover
  • The platelet count must be > 75,000 mm^3 prior to starting every cycle of treatment with decitabine; decitabine may be delayed for up to 4 weeks between cycles (i.e. may be administered as infrequently as every (q) 8 weeks) while waiting for counts to recover
  • ALLOGENEIC TRANSPLANTATION:
  • Patients must be > 30 days and < 90 days from the start of induction or re-induction chemotherapy, or > 30 days and < 90 days of recovery from consolidation cycle 1 (if received), and must have achieved a response to induction therapy (CR, CRi, or "morphologic disease-free state", documented > 27 days after start of most-recent chemotherapy)
  • Patients must have recovered from the effects of induction, re-induction, or consolidation chemotherapy (all toxicities =< grade I with the exception of reversible electrolyte abnormalities), and have no ongoing active infection requiring treatment
  • Patients must have a total serum bilirubin =< 1.5 x ULN (grade =< 1) and a serum creatinine =< grade 1
  • An eligible HLA-identical donor (either related or unrelated) should be available; in sibling donors, low resolution HLA typing (A,B,DR) will be considered sufficient; in the case of unrelated donors, high-resolution class I and II typing (A, B, C, DRB1 and DQ) should be matched at all 10 loci; donors must be willing and able to undergo peripheral blood progenitor mobilization

    • HLA-identical sibling (6/6): the donor must be determined to be an HLA-identical sibling (6/6) by serologic typing for class (A, B) and low resolution molecular typing for class II (DRB1)
    • Matched unrelated donor (10/10): high resolution molecular typing at the following loci is required: HLA-A, -B, -C, -DRBL, and -DQB1
    • NOTE: for matched donors - will allow select 1 antigen mismatched sibling donors and unrelated donors in accordance with site institutional standard, as long as matched at HLA-A, HLA-B, HLA-C, and DRB1, and with advanced discussion/approval by the Study Chair and the bone marrow transplant (BMT) co-chair
  • Patients must be considered reliable enough to comply with the medication regimen and follow-up, and have social support necessary to allow this compliance
  • Patients must have a cardiac ejection fraction of >= 40%, or within institutional normal limits; a nuclear medicine gated blood pool examination is preferred; a 2-D ECHO scan is acceptable if a calculated ejection fraction is obtained and follow-up measurement of the cardiac ejection fraction will also be performed by echocardiography; measurement of cardiac ejection fraction should be within two weeks prior to allogeneic transplantation
  • Diffusion capacity of carbon monoxide (DLCO) > 40% with no symptomatic pulmonary disease
  • No known hypersensitivity to Escherichia (E.) coli-derived products
  • No human immunodeficiency virus (HIV) infection; patients with immune dysfunction are at a significantly higher risk of toxicities from intensive immunosuppressive therapies
  • Creatinine =< grade 1
  • Bilirubin =< grade 1

    • If bilirubin is 2-3 mg/dL, but direct bilirubin is normal then patient will be considered eligible
  • AST =< grade 1
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085408


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States, 85719
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Saint Anthony Central Hospital
Denver, Colorado, United States, 80204
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Swedish Medical Center
Englewood, Colorado, United States, 80110
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Atlanta Regional CCOP
Atlanta, Georgia, United States, 30342
Northside Hospital
Atlanta, Georgia, United States, 30342
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
Georgia Regents University
Augusta, Georgia, United States, 30912
Well Star Cobb Hospital
Austell, Georgia, United States, 30106
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Piedmont Fayette Hospital
Fayetteville, Georgia, United States, 30214
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, United States, 30165
United States, Hawaii
Kapiolani Medical Center at Pali Momi
'Aiea, Hawaii, United States, 96701
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi
'Aiea, Hawaii, United States, 96701
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States, 96817-3169
Kuakini Medical Center
Honolulu, Hawaii, United States, 96817
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Saint Anthony's Health
Alton, Illinois, United States, 62002
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61701
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
Mount Sinai Hospital Medical Center
Chicago, Illinois, United States, 60608
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60611
University of Illinois
Chicago, Illinois, United States, 60612
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Eureka Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Havana
Havana, Illinois, United States, 62644
Mason District Hospital
Havana, Illinois, United States, 62644
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States, 60035
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States, 60521
Presence Saint Mary's Hospital
Kankakee, Illinois, United States, 60901
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61603
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Swedish American Hospital
Rockford, Illinois, United States, 61104
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard
Fort Wayne, Indiana, United States, 46845
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Norton Health Care Pavilion - Downtown
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation-Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States, 70115
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maine
Harold Alfond Center for Cancer Care
Augusta, Maine, United States, 04330
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-8936
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Union Hospital of Cecil County
Elkton, Maryland, United States, 21921
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Caritas Saint Elizabeth's Medical Center
Brighton, Massachusetts, United States, 02135-2997
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Wayne State University
Detroit, Michigan, United States, 48202
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Health Partners-Mercy Campus
Muskegon, Michigan, United States, 49444
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Providence Hospital
Southfield, Michigan, United States, 48075
Munson Medical Center
Traverse City, Michigan, United States, 49684
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States, 56537
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, United States, 63141
United States, Montana
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Billings Clinic
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
United States, Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Park Ridge Hospital Breast Health Center
Hendersonville, North Carolina, United States, 28792
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
United States, North Dakota
Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58122
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Summa Akron City Hospital
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Barberton Hospital
Barberton, Ohio, United States, 44203
Aultman Health Foundation
Canton, Ohio, United States, 44710
The Jewish Hospital
Cincinnati, Ohio, United States, 45236
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Grandview Hospital
Dayton, Ohio, United States, 45405
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Dayton CCOP
Dayton, Ohio, United States, 45420
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Saint Rita's Medical Center
Lima, Ohio, United States, 45801
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Columbia River Oncology Program
Portland, Oregon, United States, 97225
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazelton
Hazleton, Pennsylvania, United States, 18201
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
York Hospital
York, Pennsylvania, United States, 17405
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Carolina Blood and Cancer Care Associates PA-Lancaster
Lancaster, South Carolina, United States, 29720
Carolina Blood and Cancer Care Associates PA
Rock Hill, South Carolina, United States, 29732
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Upstate Carolina CCOP
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Washington
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
United States, West Virginia
West Virginia University Charleston
Charleston, West Virginia, United States, 25304
West Virginia University
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States, 53066-3896
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States, 53188
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
India
Mayo Clinic Methodist Hospital
Nagpur, India, 440 018
Israel
Rambam Medical Center
Haifa, Israel, 31096
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: James Foran Eastern Cooperative Oncology Group
More Information

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT02085408     History of Changes
Obsolete Identifiers: NCT01041703
Other Study ID Numbers: E2906
NCI-2011-01992 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000659585
ECOG-E2906
E2906 ( Other Identifier: Eastern Cooperative Oncology Group )
E2906 ( Other Identifier: CTEP )
U10CA021115 ( U.S. NIH Grant/Contract )
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia, Monocytic, Acute
Leukemia, Myelomonocytic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Erythroblastic, Acute
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myeloproliferative Disorders
Cytarabine
Decitabine
Azacitidine
Clofarabine
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors