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

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)

Sponsors

Lead Sponsor: Eastern Cooperative Oncology Group

Collaborator: National Cancer Institute (NCI)

Source Eastern Cooperative Oncology Group
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.

Detailed Description

PRIMARY OBJECTIVES:

I. 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:

I. 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.

II. 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.

III. 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.

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

V. 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.

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

VII. 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.

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

IX. 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).

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

TERTIARY OBJECTIVES:

I. 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.

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

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

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

V. 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.

Overall Status Active, not recruiting
Start Date December 28, 2010
Primary Completion Date June 30, 2019
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Overall survival Time between randomization and death from any cause, assessed up to 5 years
Secondary Outcome
Measure Time Frame
Mortality rate 30 days
Induction complete response rates Up to 5 years
Disease-free survival (DFS) Time from the second randomization to relapse or death without relapse, assessed up to 5 years
Overall survival Up to 5 years
Epidemiological factors, measured using the Acute Leukemia Epidemiology and Survival in ECOG (ALESE) questionnaire Baseline
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
Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score Baseline to 30 days after beginning induction therapy
Enrollment 727
Condition
Intervention

Intervention Type: Drug

Intervention Name: clofarabine

Description: Given IV

Arm Group Label: Arm II (clofarabine)

Intervention Type: Drug

Intervention Name: daunorubicin hydrochloride

Description: Given IV

Arm Group Label: Arm I (daunorubicin hydrochloride and cytarabine)

Intervention Type: Other

Intervention Name: clinical observation

Description: Undergo clinical observation

Arm Group Label: Arm I (daunorubicin hydrochloride and cytarabine)

Other Name: observation

Intervention Type: Drug

Intervention Name: cytarabine

Description: Given IV

Arm Group Label: Arm I (daunorubicin hydrochloride and cytarabine)

Intervention Type: Drug

Intervention Name: decitabine

Description: Given IV

Arm Group Label: Arm II (clofarabine)

Intervention Type: Other

Intervention Name: laboratory biomarker analysis

Description: Correlative studies

Intervention Type: Procedure

Intervention Name: quality-of-life assessment

Description: Ancillary studies

Other Name: quality of life assessment

Intervention Type: Other

Intervention Name: questionnaire administration

Description: Ancillary studies

Eligibility

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

Gender: All

Minimum Age: 60 Years

Maximum Age: N/A

Healthy Volunteers: No

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

India

Israel

United States

Verification Date

December 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm I (daunorubicin hydrochloride and cytarabine)

Type: Active Comparator

Description: See Detailed Description

Label: Arm II (clofarabine)

Type: Experimental

Description: See Detailed Description

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov