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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

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02085408
Collaborator
National Cancer Institute (NCI) (NIH)
727
Enrollment
269
Locations
2
Arms
165.1
Anticipated Duration (Months)
2.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

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
Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. To evaluate the effect of clofarabine induction and consolidation therapy on overall survival in comparison with standard therapy (daunorubicin [daunorubicin hydrochloride] & cytarabine) in newly-diagnosed acute myeloid leukemia (AML) patients age >= 60 years.
SECONDARY OBJECTIVES:

  1. To evaluate complete remission (CR) rates, duration of remission, and toxicity/treatment-related mortality of clofarabine in comparison with standard therapy (daunorubicin & cytarabine) in newly-diagnosed AML patients age >= 60 years.

  2. To evaluate the feasibility of consolidation with reduced-intensity conditioning and allogeneic hematopoietic stem cell transplantation from human leukocyte antigen (HLA)-identical donors in patients who achieve a response to induction therapy, including the incidence of successful engraftment, acute and chronic graft-versus-host disease, transplant-related mortality, and its impact on overall survival in comparison to patients receiving chemotherapy.

  3. To evaluate the duration of remission and disease-free survival of patients in complete remission following completion of consolidation therapy who are subsequently randomized to receive scheduled low-dose decitabine maintenance in comparison with observation.

  4. To perform expression and methylation profiling on all patients receiving decitabine and to correlate their integrated epigenetic signatures with response to decitabine.

  5. To examine the epigenetic profiles of remission marrow in patients randomized to observation vs. decitabine to determine whether epigenetic signature of apparently morphologically normal bone marrow is predictive of relapse or response to decitabine maintenance.

  6. To explore the possible association of response to clofarabine with ABC-transporter P-glycoprotein (Pgp).

  7. To assess the intensity of expression of CXC chemokine receptor type 4 (CXCR4) on diagnostic leukemia cells and to correlate this parameter with other established prognostic factors.

  8. To assess the entire spectrum of somatic mutations and affected pathways at diagnosis of AML and elucidate the association between gene mutation and outcome.

  9. To examine the impact of smoking, obesity, regular acetaminophen use, regular aspirin use, benzene exposure, living in a rural/farm environment and some other underlying exposures and lifestyle factors associated with AML development on overall survival (OS).

  10. To investigate potential correlative results between array comparative genomic hybridization (CGH) findings and acute myeloid leukemia patient characteristics.

TERTIARY OBJECTIVES:

  1. To compare health-related quality of life (QOL) (physical, functional, leukemia-specific well-being) and fatigue in elderly AML patients receiving standard induction therapy with those receiving clofarabine.

  2. To measure the change in health-related QOL that occurs over time (within treatment groups).

  3. To comprehensively assess patient function at the time of study enrollment.

  4. To determine if components of a comprehensive geriatric assessment or QOL scales predict ability to complete AML treatment.

  5. To describe the impact of transplant on QOL in AML patients above age 60.

OUTLINE:

INDUCTION THERAPY: Patients are randomized to 1 of 2 treatment arms.

ARM I (STANDARD THERAPY): Patients receive daunorubicin hydrochloride intravenously (IV) over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients with residual disease or those who do not achieve an aplastic bone marrow on day 12-14 (i.e., < 5% blasts and < 20% cellularity or markedly/moderately hypocellular) may receive a second course of induction therapy beginning no sooner than day 14.

ARM II: Patients receive clofarabine IV over 1 hour on days 1-5. Patients with residual disease or those who do not achieve an aplastic bone marrow on day 12-14 (i.e., < 5% blasts and < 20% cellularity or markedly/moderately hypocellular) may receive a second course of induction therapy beginning no sooner than day 21 and no later than day 56.

Patients who achieve a complete remission (CR) or CR with incomplete marrow recovery (CRi) after induction therapy proceed to consolidation therapy. Patients who are 60-69 years of age who achieve a "morphologic leukemia-free state" after induction therapy and who have an HLA-identical donor proceed to allogeneic stem cell transplantation.

CONSOLIDATION THERAPY: Beginning within 60 days after documentation of CR or CRi, patients receive consolidation therapy in the same arm they were randomized to for induction therapy.

ARM I (STANDARD THERAPY): Patients receive cytarabine IV over 1 hour once or twice daily on days 1-6. Treatment repeats every 4-6 weeks for 2 courses.

ARM II: Patients receive clofarabine IV over 1 hour on days 1-5. Treatment repeats every 4-6 weeks for 2 courses.

Patients who remain in CR after completion of consolidation therapy proceed to maintenance therapy.

MAINTENANCE THERAPY: Beginning within 60 days after completion of consolidation therapy, patients receive maintenance therapy and are randomized to 1 of 2 arms. Patients not eligible for randomization to decitabine maintenance after recovery from consolidation will be followed according to Arm I.

ARM I: Patients undergo observation monthly for 12 months.

ARM II: Patients receive decitabine IV over 1 hour on days 1-3. Treatment repeats every 4 weeks for 12 months the absence of unacceptable toxicity.

ALLOGENEIC STEM CELL TRANSPLANTATION WITH REDUCED-INTENSITY CONDITIONING REGIMEN: Patients begin reduced-intensity conditioning 30-90 days after the initiation of induction therapy.

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 2 hours every 6 hours on days -4 and -3 (for a total of 8 doses), and anti-thymocyte globulin IV over 4-6 hours on days -4 to -2.

TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

After completion of study treatment, patients are followed up every 3 months for 4 years, every 6 months for 1 year, and then annually thereafter.

Study Design

Study Type:
Interventional
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 &gt;/= 60 Years)
Actual Study Start Date :
Dec 28, 2010
Anticipated Primary Completion Date :
Mar 15, 2021
Anticipated Study Completion Date :
Oct 1, 2024

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 Names:
  • 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 Names:
  • 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 Names:
  • quality of life assessment

    • Other: questionnaire administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [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 [30 days]

    2. Induction complete response rates [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 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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
    3 Arizona Cancer Center at University Medical Center North Tucson Arizona United States 85719
    4 University of Arizona Health Sciences Center Tucson Arizona United States 85724
    5 The Medical Center of Aurora Aurora Colorado United States 80012
    6 Boulder Community Hospital Boulder Colorado United States 80301
    7 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    8 Saint Anthony Central Hospital Denver Colorado United States 80204
    9 Porter Adventist Hospital Denver Colorado United States 80210
    10 Exempla Saint Joseph Hospital Denver Colorado United States 80218
    11 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
    12 Rose Medical Center Denver Colorado United States 80220
    13 Colorado Cancer Research Program CCOP Denver Colorado United States 80224-2522
    14 Swedish Medical Center Englewood Colorado United States 80110
    15 North Colorado Medical Center Greeley Colorado United States 80631
    16 Littleton Adventist Hospital Littleton Colorado United States 80122
    17 Sky Ridge Medical Center Lone Tree Colorado United States 80124
    18 Longmont United Hospital Longmont Colorado United States 80501
    19 McKee Medical Center Loveland Colorado United States 80539
    20 Parker Adventist Hospital Parker Colorado United States 80138
    21 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    22 North Suburban Medical Center Thornton Colorado United States 80229
    23 Exempla Lutheran Medical Center Wheat Ridge Colorado United States 80033
    24 Saint Francis Hospital and Medical Center Hartford Connecticut United States 06105
    25 The Hospital of Central Connecticut New Britain Connecticut United States 06050
    26 Beebe Medical Center Lewes Delaware United States 19958
    27 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    28 University of Florida Gainesville Florida United States 32610
    29 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
    30 Florida Hospital Orlando Florida United States 32803
    31 Piedmont Hospital Atlanta Georgia United States 30309
    32 Atlanta Regional CCOP Atlanta Georgia United States 30342
    33 Northside Hospital Atlanta Georgia United States 30342
    34 Saint Joseph's Hospital of Atlanta Atlanta Georgia United States 30342
    35 Georgia Regents University Augusta Georgia United States 30912
    36 Well Star Cobb Hospital Austell Georgia United States 30106
    37 John B Amos Cancer Center Columbus Georgia United States 31904
    38 Dekalb Medical Center Decatur Georgia United States 30033
    39 Piedmont Fayette Hospital Fayetteville Georgia United States 30214
    40 Gwinnett Medical Center Lawrenceville Georgia United States 30045
    41 Wellstar Kennestone Hospital Marietta Georgia United States 30060
    42 Southern Regional Medical Center Riverdale Georgia United States 30274
    43 Harbin Clinic Medical Oncology and Clinical Research Rome Georgia United States 30165
    44 Kapiolani Medical Center at Pali Momi 'Aiea Hawaii United States 96701
    45 Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi 'Aiea Hawaii United States 96701
    46 Oncare Hawaii Inc-POB II Honolulu Hawaii United States 96813
    47 Queen's Medical Center Honolulu Hawaii United States 96813
    48 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    49 University of Hawaii Honolulu Hawaii United States 96813
    50 OnCare Hawaii-Liliha Honolulu Hawaii United States 96817-3169
    51 Kuakini Medical Center Honolulu Hawaii United States 96817
    52 Oncare Hawaii Inc-Kuakini Honolulu Hawaii United States 96817
    53 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    54 Castle Medical Center Kailua Hawaii United States 96734
    55 Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii United States 96766
    56 Saint Alphonsus Regional Medical Center Boise Idaho United States 83706
    57 Saint Anthony's Health Alton Illinois United States 62002
    58 Illinois CancerCare-Bloomington Bloomington Illinois United States 61701
    59 Saint Joseph Medical Center Bloomington Illinois United States 61701
    60 Graham Hospital Association Canton Illinois United States 61520
    61 Illinois CancerCare-Canton Canton Illinois United States 61520
    62 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    63 Memorial Hospital Carthage Illinois United States 62321
    64 Mount Sinai Hospital Medical Center Chicago Illinois United States 60608
    65 Hematology and Oncology Associates Chicago Illinois United States 60611
    66 Northwestern University Chicago Illinois United States 60611
    67 University of Illinois Chicago Illinois United States 60612
    68 Decatur Memorial Hospital Decatur Illinois United States 62526
    69 Eureka Hospital Eureka Illinois United States 61530
    70 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    71 Illinois CancerCare Galesburg Galesburg Illinois United States 61401
    72 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    73 Illinois CancerCare-Havana Havana Illinois United States 62644
    74 Mason District Hospital Havana Illinois United States 62644
    75 Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois United States 60035
    76 Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois United States 60521
    77 Presence Saint Mary's Hospital Kankakee Illinois United States 60901
    78 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    79 North Shore Hematology Oncology Libertyville Illinois United States 60048
    80 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    81 Mcdonough District Hospital Macomb Illinois United States 61455
    82 Loyola University Medical Center Maywood Illinois United States 60153
    83 Holy Family Medical Center Monmouth Illinois United States 61462
    84 Illinois CancerCare-Monmouth Monmouth Illinois United States 61462
    85 Illinois Cancer Specialists-Niles Niles Illinois United States 60714
    86 Bromenn Regional Medical Center Normal Illinois United States 61761
    87 Community Cancer Center Foundation Normal Illinois United States 61761
    88 Illinois CancerCare-Community Cancer Center Normal Illinois United States 61761
    89 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    90 Ottawa Regional Hospital and Healthcare Center Ottawa Illinois United States 61350
    91 Pekin Cancer Treatment Center Pekin Illinois United States 61554
    92 Illinois CancerCare-Pekin Pekin Illinois United States 61603
    93 Methodist Medical Center of Illinois Peoria Illinois United States 61603
    94 Proctor Hospital Peoria Illinois United States 61614
    95 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    96 Illinois Oncology Research Association CCOP Peoria Illinois United States 61615
    97 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    98 Illinois CancerCare-Peru Peru Illinois United States 61354
    99 Illinois Valley Hospital Peru Illinois United States 61354
    100 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    101 Perry Memorial Hospital Princeton Illinois United States 61356
    102 Swedish American Hospital Rockford Illinois United States 61104
    103 Hematology Oncology Associates of Illinois - Skokie Skokie Illinois United States 60076
    104 Illinois CancerCare-Spring Valley Spring Valley Illinois United States 61362
    105 Memorial Medical Center Springfield Illinois United States 62781-0001
    106 Saint Francis Hospital and Health Centers Beech Grove Indiana United States 46107
    107 Fort Wayne Medical Oncology and Hematology Inc - State Boulevard Fort Wayne Indiana United States 46845
    108 Franciscan St. Francis Health Indianapolis Indiana United States 46237
    109 Reid Hospital and Health Care Services Richmond Indiana United States 47374
    110 McFarland Clinic Ames Iowa United States 50010
    111 Siouxland Hematology Oncology Associates Sioux City Iowa United States 51101
    112 Mercy Medical Center-Sioux City Sioux City Iowa United States 51104
    113 Saint Luke's Regional Medical Center Sioux City Iowa United States 51104
    114 University of Kentucky Lexington Kentucky United States 40536
    115 Norton Health Care Pavilion - Downtown Louisville Kentucky United States 40202
    116 Ochsner Clinic Foundation-Baton Rouge Baton Rouge Louisiana United States 70809
    117 Ochsner Baptist Medical Center New Orleans Louisiana United States 70115
    118 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    119 Harold Alfond Center for Cancer Care Augusta Maine United States 04330
    120 Eastern Maine Medical Center Bangor Maine United States 04401
    121 Johns Hopkins University Baltimore Maryland United States 21287-8936
    122 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-5600
    123 Union Hospital of Cecil County Elkton Maryland United States 21921
    124 Tufts Medical Center Boston Massachusetts United States 02111
    125 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    126 Caritas Saint Elizabeth's Medical Center Brighton Massachusetts United States 02135-2997
    127 Baystate Medical Center Springfield Massachusetts United States 01199
    128 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106-0995
    129 Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor Michigan United States 48106
    130 Bronson Battle Creek Battle Creek Michigan United States 49017
    131 Mecosta County Medical Center Big Rapids Michigan United States 49307
    132 Oakwood Hospital Dearborn Michigan United States 48124
    133 Wayne State University Detroit Michigan United States 48202
    134 Saint John Hospital and Medical Center Detroit Michigan United States 48236
    135 Hurley Medical Center Flint Michigan United States 48502
    136 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    137 Genesys Regional Medical Center-West Flint Campus Flint Michigan United States 48532
    138 Genesys Regional Medical Center Grand Blanc Michigan United States 48439
    139 Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
    140 Saint Mary's Health Care Grand Rapids Michigan United States 49503
    141 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    142 Allegiance Health Jackson Michigan United States 49201
    143 Borgess Medical Center Kalamazoo Michigan United States 49001
    144 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    145 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    146 Sparrow Hospital Lansing Michigan United States 48912
    147 Saint Mary Mercy Hospital Livonia Michigan United States 48154
    148 Mercy Health Partners-Mercy Campus Muskegon Michigan United States 49444
    149 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341-2985
    150 Saint Joseph Mercy Port Huron Port Huron Michigan United States 48060
    151 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    152 Saint Mary's of Michigan Saginaw Michigan United States 48601
    153 Providence Hospital Southfield Michigan United States 48075
    154 Munson Medical Center Traverse City Michigan United States 49684
    155 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    156 Sanford Clinic North-Bemidgi Bemidji Minnesota United States 56601
    157 Essentia Health Saint Joseph's Medical Center Brainerd Minnesota United States 56401
    158 Essentia Health Duluth Clinic CCOP Duluth Minnesota United States 55805
    159 Essentia Health Saint Mary's Medical Center Duluth Minnesota United States 55805
    160 Miller-Dwan Hospital Duluth Minnesota United States 55805
    161 Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota United States 56537
    162 Mayo Clinic Rochester Minnesota United States 55905
    163 University of Mississippi Medical Center Jackson Mississippi United States 39216
    164 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    165 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    166 Saint Louis University Hospital Saint Louis Missouri United States 63110
    167 Washington University School of Medicine Saint Louis Missouri United States 63110
    168 Saint John's Mercy Medical Center Saint Louis Missouri United States 63141
    169 Saint Louis-Cape Girardeau CCOP Saint Louis Missouri United States 63141
    170 Montana Cancer Consortium CCOP Billings Montana United States 59101
    171 Saint Vincent Healthcare Billings Montana United States 59101
    172 Hematology-Oncology Centers of the Northern Rockies PC Billings Montana United States 59102
    173 Billings Clinic Billings Montana United States 59107-7000
    174 Bozeman Deaconess Cancer Center Bozeman Montana United States 59715
    175 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    176 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    177 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    178 Great Falls Clinic Great Falls Montana United States 59405
    179 Northern Montana Hospital Havre Montana United States 59501
    180 Saint Peter's Community Hospital Helena Montana United States 59601
    181 Glacier Oncology PLLC Kalispell Montana United States 59901
    182 Kalispell Medical Oncology Kalispell Montana United States 59901
    183 Kalispell Regional Medical Center Kalispell Montana United States 59901
    184 Montana Cancer Specialists Missoula Montana United States 59802
    185 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    186 Nevada Cancer Research Foundation CCOP Las Vegas Nevada United States 89106
    187 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    188 Winthrop University Hospital Mineola New York United States 11501
    189 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    190 University of Rochester Rochester New York United States 14642
    191 Park Ridge Hospital Breast Health Center Hendersonville North Carolina United States 28792
    192 Kinston Medical Specialists PA Kinston North Carolina United States 28501
    193 Roger Maris Cancer Center Fargo North Dakota United States 58122
    194 Sanford Clinic North-Fargo Fargo North Dakota United States 58122
    195 Sanford Medical Center-Fargo Fargo North Dakota United States 58122
    196 Summa Akron City Hospital Akron Ohio United States 44304
    197 Akron General Medical Center Akron Ohio United States 44307
    198 Summa Barberton Hospital Barberton Ohio United States 44203
    199 Aultman Health Foundation Canton Ohio United States 44710
    200 The Jewish Hospital Cincinnati Ohio United States 45236
    201 Case Western Reserve University Cleveland Ohio United States 44106
    202 Grandview Hospital Dayton Ohio United States 45405
    203 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
    204 Miami Valley Hospital Dayton Ohio United States 45409
    205 Samaritan North Health Center Dayton Ohio United States 45415
    206 Dayton CCOP Dayton Ohio United States 45420
    207 Blanchard Valley Hospital Findlay Ohio United States 45840
    208 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    209 Wayne Hospital Greenville Ohio United States 45331
    210 Kettering Medical Center Kettering Ohio United States 45429
    211 Saint Rita's Medical Center Lima Ohio United States 45801
    212 Upper Valley Medical Center Troy Ohio United States 45373
    213 Clinton Memorial Hospital Wilmington Ohio United States 45177
    214 Greene Memorial Hospital Xenia Ohio United States 45385
    215 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    216 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    217 Providence Milwaukie Hospital Milwaukie Oregon United States 97222
    218 Providence Newberg Medical Center Newberg Oregon United States 97132
    219 Providence Willamette Falls Medical Center Oregon City Oregon United States 97045
    220 Providence Portland Medical Center Portland Oregon United States 97213
    221 Columbia River Oncology Program Portland Oregon United States 97225
    222 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    223 Lehigh Valley Hospital Allentown Pennsylvania United States 18105
    224 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    225 Geisinger Medical Center Danville Pennsylvania United States 17822-2001
    226 Geisinger Medical Center-Cancer Center Hazelton Hazleton Pennsylvania United States 18201
    227 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    228 Lewistown Hospital Lewistown Pennsylvania United States 17044
    229 Abramson Cancer Center of The University of Pennsylvania Philadelphia Pennsylvania United States 19104
    230 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111-2497
    231 Geisinger Medical Group State College Pennsylvania United States 16801
    232 Mount Nittany Medical Center State College Pennsylvania United States 16803
    233 Geisinger Wyoming Valley Wilkes-Barre Pennsylvania United States 18711
    234 York Hospital York Pennsylvania United States 17405
    235 AnMed Health Cancer Center Anderson South Carolina United States 29621
    236 Saint Francis Hospital Greenville South Carolina United States 29601
    237 Carolina Blood and Cancer Care Associates PA-Lancaster Lancaster South Carolina United States 29720
    238 Carolina Blood and Cancer Care Associates PA Rock Hill South Carolina United States 29732
    239 Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
    240 Upstate Carolina CCOP Spartanburg South Carolina United States 29303
    241 Sanford Cancer Center-Oncology Clinic Sioux Falls South Dakota United States 57104
    242 Medical X-Ray Center Sioux Falls South Dakota United States 57105
    243 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    244 Erlanger Medical Center Chattanooga Tennessee United States 37403
    245 Jackson-Madison County General Hospital Jackson Tennessee United States 38301
    246 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232
    247 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    248 Northwest Cancer Specialists Vancouver Washington United States 98684
    249 West Virginia University Charleston Charleston West Virginia United States 25304
    250 West Virginia University Morgantown West Virginia United States 26506
    251 Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin United States 54301-3526
    252 Saint Vincent Hospital Green Bay Wisconsin United States 54301
    253 Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin United States 54303
    254 Saint Mary's Hospital Green Bay Wisconsin United States 54303
    255 Gundersen Lutheran La Crosse Wisconsin United States 54601
    256 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    257 Holy Family Memorial Hospital Manitowoc Wisconsin United States 54221
    258 Bay Area Medical Center Marinette Wisconsin United States 54143
    259 Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    260 D N Greenwald Center Mukwonago Wisconsin United States 53149
    261 Oconomowoc Memorial Hospital-ProHealth Care Inc Oconomowoc Wisconsin United States 53066-3896
    262 Saint Nicholas Hospital Sheboygan Wisconsin United States 53081
    263 Waukesha Memorial Hospital - ProHealth Care Waukesha Wisconsin United States 53188
    264 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    265 Rocky Mountain Oncology Casper Wyoming United States 82609
    266 Welch Cancer Center Sheridan Wyoming United States 82801
    267 Mayo Clinic Methodist Hospital Nagpur India 440 018
    268 Rambam Medical Center Haifa Israel 31096
    269 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eastern Cooperative Oncology Group
    ClinicalTrials.gov Identifier:
    NCT02085408
    Other Study ID Numbers:
    • E2906
    • NCI-2011-01992
    • CDR0000659585
    • ECOG-E2906
    • E2906
    • E2906
    • U10CA021115
    • NCT01041703
    First Posted:
    Mar 12, 2014
    Last Update Posted:
    Feb 25, 2021
    Last Verified:
    Oct 1, 2020
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Leukemia, Monocytic, Acute
    Leukemia, Myelomonocytic, Acute
    Leukemia, Megakaryoblastic, Acute
    Leukemia, Erythroblastic, Acute
    Myelodysplastic Syndromes
    Cytarabine
    Decitabine
    Clofarabine
    Azacitidine
    Daunorubicin

    Study Results

    No Results Posted as of Feb 25, 2021