S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia

NCT00840177 | Completed Phase 2 Results DMC

• 3 other identifiers: S0919U10CA032102NCI-2009-01183
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 185

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together with pravastatin may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with pravastatin works in treating patients with relapsed acute myeloid leukemia (AML). ADDITIONAL BACKGROUND: S0919 was initially designed for patients with relapsed acute myeloid leukemia (AML), where the patient's preceding remission had lasted ≥ 3 months. The null response rate was 30%. The study closed to accrual on Nov 1, 2012 after meeting the defined criterion for a positive study; and the results are being submitted to the American Society of Clinical Oncology meeting. Based on the promising results from this trial, the trial has now been amended to evaluate this therapeutic regimen in poor-risk patients (patients with newly diagnosed acute myeloid leukemia (AML) arising out of myelodysplastic syndrome (MDS), primary refractory acute myeloid leukemia (AML), and relapsed acute myeloid leukemia (AML) with the patient's preceding remission lasting \< 6 months).

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22)

Outcome Measures

Primary Outcomes (1)

• Complete Remission (CR) Rate (Including CR With Incomplete Recovery)

  Participants who achieved morphological complete remission with or without incomplete blood count recovery. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.

  Up to 5 years after registration

Secondary Outcomes (1)

• Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0

  Up to 5 years post registration

Other Outcomes (3)

• Correlation Between Pre-study Cytogenetic Features and Response

  5 years

• Overall Survival (OS)

  OS assessed for up to 5 years, median OS reported

• Relapse-free Survival (RFS)

  RFS assessed for up to 5 years, median RFS reported

Study Arms (1)

treatment

EXPERIMENTAL

Induction (1 cycle): pravastatin 1280 mg/d PO D 1-8 idarubicin 12 mg/m2/d IV D 4-6 cytarabine 1.5 g/m2/d continuous IV D 4-7 Consolidation (up to 2 cycles): pravastatin 1280 mg/d PO D 1-6 idarubicin 12 mg/m2/d IV D 4-5 cytarabine 1.5 g/m2/d continuous IV D 4-5

Drug: cytarabine; Drug: idarubicin; Drug: pravastatin sodium

Interventions

cytarabine DRUG

1.5 g/m2/day given by continuous IV on days 4-7

treatment

idarubicin DRUG

12 mg/m2/day given intravenously over 10-15 minutes on days 4-6

treatment

pravastatin sodium DRUG

1,280 mg/day given orally on days 1-8

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Cohort 1 (Initial cohort: Relapsed AML with previous remission \>/= 3 months) is permanently closed to accrual DISEASE CHARACTERISTICS * Patients must have a previous morphologically confirmed diagnosis of acute myeloid leukemia (AML). Note: This protocol uses the World Health Organization (WHO) diagnostic criteria for acute myeloid leukemia (AML) (see Section 4.1). Patients with acute promyelocytic leukemia (APL, FAB, M3) or blastic transformation of chronic myelogenous leukemia (CMML) are not eligible. * Patients must have received at least one prior chemotherapy regimen for their acute myeloid leukemia (AML) and they may have received any type of chemotherapy. They must have achieved complete remission (CR), lasting at least three months with their last induction regimen and they must have relapsed after the last regimen. Relapse must be documented by a bone marrow examination demonstrating \> 5% blasts in the bone marrow not attributable to another cause. Refractory patients and patients who have received autologous or allogeneic stem cell transplantation are not eligible. Administration of hydroxyurea to control high white blood cell (WBC) count prior to, during and after registration is permitted. * Patients must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias. Either an echocardiogram or multiple-gated acquisition (MUGA) scan with an ejection fraction ≥ 45% must be obtained within 28 days prior to registration. (Either method for measuring cardiac function is acceptable, however, the same scan must be used throughout treatment and follow-up to monitor the patient for cardiac toxicity.) If patient has symptoms suggestive of ischemia or congestive heart failure after that cardiac evaluation was done, a repeat study must be obtained prior to registration. * Patients must have a serum creatinine \< 2.0 mg/dl within 14 days prior to registration. * Patients must have a total bilirubin ≤ 2.0 x Institutional Upper Limit of Normal (IULN) within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction. * Patients must have SGOT (AST) ≤ 3.0 x IULN and SGPT (ALT) ≤ 3.0 x IULN within 14 days prior to registration. Treatment may begin with SGOT/SGPT above those limits, if the abnormalities are thought to be due to the patient's leukemia. * Patients must have Zubrod performance status of 0-2 (see Section 10.8). * Patients must be ≥ 18 years of age. * Patients must not have clinical evidence of leptomeningeal disease (a spinal tap does not need to be performed). * Patients not known to be HIV+ must be tested for HIV infection (the human immunodeficiency virus) within 14 days prior to registration (see Section 2.0 for justification). Patients who are HIV+ may be eligible providing they meet all of the following additional criteria within 14 days prior to registration: 1. Patient must have no history of AIDS defining events. 2. CD4 cells ≥ 500/mm3. 3. Viral load of \< 50 copies HIV mRNA/mm3 if on cART or \< 25,000 copies HIV mRNA if not on cART. 4. No zidovudine or stavudine as part of cART. Patients who are HIV+ and do not meet all of these criteria will not be eligible for this study. * Patients with prior malignancy (other than AML) are eligible. However, the patient must be in remission from the prior malignancy and have completed all chemotherapy and radiotherapy at least 6 months prior to registration and all treatment related toxicities must have been resolved. NOTE: For patients with prior history of malignancy who have received anthracyclines or mediastinal/pericardial radiation in the past, the risk versus benefit of therapy should be weighed, particularly in the setting of receiving consolidation therapy. * Patients must not have a systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment). * Southwest Oncology Group patients must be registered on SWOG-9007 ("Cytogenetic Studies in Leukemia Patients"). Collection of pretreatment marrow specimens must be completed within 28 days prior to registration. Pretreatment specimens of bone marrow (or peripheral blood if the marrow aspirate is a dry tap) must be submitted to an approved Southwest Oncology Group Cytogenetics Laboratory for cytogenetics analysis. Note that protocol SWOG-9007 also requires submission of specimens at additional timepoints. * Southwest Oncology Group patients must be offered participation in S9910 ("Leukemia Centralized Reference Laboratories and Tissue Repositories Ancillary"). If consent is given, collection of pretreatment blood and/or marrow specimens must be completed within 28 days prior to registration. If the patient consents to participate in S9910, pretreatment specimens of marrow and/or peripheral blood must be submitted to the Southwest Oncology Group Myeloid Repository at the University of New Mexico for cellular and molecular studies. Note that protocol S9910 also requests submission of specimens at additional timepoints. * Women of reproductive potential must have a negative pregnancy test within 14 days prior to registration. Patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study. Women/men of reproductive potential must have agreed to use an effective contraceptive method. * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. * At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base. Cohort 2 (MDS transformed to AML) is permanently closed to accrual AND Cohort 3 (relapsed/refractory AML) is permanently closed to accrual DISEASE CHARACTERISTICS: * For patients registered to relapsed/refractory (Cohort 3), morphologically confirmed diagnosis of acute myeloid leukemia (AML) * Patient registered to the myelodysplastic syndrome (MDS) transformed to acute myeloid leukemia (AML) cohort (Cohort 2) patients must have a previous morphologically confirmed diagnosis of myelodysplastic syndrome/chronic myelomonocytic leukemia (MDS/CMML). Patients may have received previous non-intensive therapy (such as: azacitidine, decitabine, low-dose cytarabine, lenalidomide) given treatment of myelodysplastic syndrome/chronic myelomonocytic leukemia (MDS/CMML) (with up to 20% blasts). At time of registration, patient must have morphologically confirmed diagnosis of acute myeloid leukemia (AML). * Patients with acute promyelocytic leukemia (i.e., APL, FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible * Patients must not have received autologous or allogeneic stem cell transplant. * Patients in the relapsed/refractory acute myeloid leukemia (AML) cohort (Cohort 3) must: * Have received ≥ 1 prior chemotherapy regimen for acute myeloid leukemia (AML) * Any type of prior chemotherapy allowed * Administration of hydroxyurea to control high white blood cell (WBC) prior to, during, and after registration is permitted * Relapse must be documented by a bone marrow examination demonstrating \> 5% blasts in the bone marrow not attributable to another cause * Patient must not have received chemo within 14 days prior to registration * Primary refractory patients eligible if, on Day 14 of previous chemo regimen, they have significant residual disease. Patients who received only hypomethylating agent or low dose therapy for Induction are not considered primary refractory for this study and are not eligible. * Relapsed patients must have achieved a complete remission (CR) or CR with incomplete blood count recovery that lasted \< 6 months after the last induction regimen * No clinical evidence of leptomeningeal disease * Pretreatment (collected within 28 days of registration) cytogenetics must be performed on all patients. * Patients must have complete history and physical exam within 28 days prior to registration. PATIENT CHARACTERISTICS: * No symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias * Ejection fraction ≥ 45% by echocardiogram or MUGA scan within 28 days prior to registration (or within 14 days prior to registration if the patient has received anthracycline in the 28 day window) * Zubrod performance status 0-2 * Serum creatinine ≤ 2.0 times upper limit of normal (ULN) * Total bilirubin ≤ 2.0 times ULN (unless elevation is primarily due to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis AND not due to liver dysfunction) * AST and ALT ≤ 3.0 times ULN * Not pregnant or nursing and negative pregnancy test within 14 days prior to registration. Females of child-bearing potential must agree to use effective contraception * No HIV positivity unless the following criteria are met: * No history of AIDS-defining events * CD4 count ≥ 500/mm³ * Viral load \< 25,000 copies (\< 50 copies if on combination antiretroviral therapy) * Not receiving zidovudine or stavudine as part of combination antiretroviral therapy * No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs/symptoms related to the infection with no improvement despite appropriate antibiotics or other treatment * Patients with prior malignancy (other than AML and MDS/CMML) eligible provided patient is in remission from that malignancy at least 6 months prior to registration. Except for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) treatment, all treatment related toxicities must have been resolved.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (185)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States

Location

Kootenai Medical Center

Coeur d'Alene, Idaho, 83814, United States

Location

Walter Knox Memorial Hospital

Emmett, Idaho, 83617, United States

Location

Idaho Urologic Institute-Meridian

Meridian, Idaho, 83642, United States

Location

Saint Alphonsus Medical Center-Nampa

Nampa, Idaho, 83686, United States

Location

Kootenai Cancer Center

Post Falls, Idaho, 83854, United States

Location

Kootenai Cancer Clinic

Sandpoint, Idaho, 83864, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902, United States

Location

SIH Cancer Institute

Carterville, Illinois, 62918, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

Location

Cancer Care Center of Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Radiation Oncology of Northern Illinois

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

Location

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, 61554, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61603, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

Location

Valley Radiation Oncology

Peru, Illinois, 61354, United States

Location

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62702, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Springfield Clinic

Springfield, Illinois, 62702, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Cancer Care Specialists of Illinois-Swansea

Swansea, Illinois, 62226, United States

Location

Memorial and Saint Elizabeth's Health Care Services LLP

Swansea, Illinois, 62226, United States

Location

Hospital District Sixth of Harper County

Anthony, Kansas, 67003, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Cancer Center of Kansas-Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas-Liberal

Liberal, Kansas, 67905, United States

Location

Cancer Center of Kansas-Manhattan

Manhattan, Kansas, 66502, United States

Location

Cancer Center of Kansas - McPherson

McPherson, Kansas, 67460, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates In Womens Health

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Wichita NCI Community Oncology Research Program

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Hematology/Oncology Clinic LLP

Baton Rouge, Louisiana, 70809, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, 71103, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, 48106, United States

Location

IHA Hematology Oncology Consultants-Brighton

Brighton, Michigan, 48114, United States

Location

Saint Joseph Mercy Brighton

Brighton, Michigan, 48114, United States

Location

IHA Hematology Oncology Consultants-Canton

Canton, Michigan, 48188, United States

Location

Saint Joseph Mercy Canton Health Center

Canton, Michigan, 48188, United States

Location

Caro Cancer Center

Caro, Michigan, 48723, United States

Location

IHA Hematology Oncology Consultants-Chelsea

Chelsea, Michigan, 48118, United States

Location

Saint Joseph Mercy Chelsea

Chelsea, Michigan, 48118, United States

Location

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, 48346, United States

Location

Newland Medical Associates-Clarkston

Clarkston, Michigan, 48346, United States

Location

Beaumont Hospital-Dearborn

Dearborn, Michigan, 48124, United States

Location

Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Great Lakes Cancer Management Specialists-Doctors Park

East China Township, Michigan, 48054, United States

Location

Hurley Medical Center

Flint, Michigan, 48502, United States

Location

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, 48503, United States

Location

Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Lymphoma Clinic of Michigan

Grosse Pointe Woods, Michigan, 48236, United States

Location

Michigan Breast Specialists-Grosse Pointe Woods

Grosse Pointe Woods, Michigan, 48236, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Hope Cancer Clinic

Livonia, Michigan, 48154, United States

Location

Saint Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Hematology Oncology Associates East PC

Macomb, Michigan, 48044, United States

Location

Michigan Breast Specialists-Macomb Township

Macomb, Michigan, 48044, United States

Location

21st Century Oncology-Pontiac

Pontiac, Michigan, 48341, United States

Location

Hope Cancer Center

Pontiac, Michigan, 48341, United States

Location

Newland Medical Associates-Pontiac

Pontiac, Michigan, 48341, United States

Location

Saint Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States

Location

Lake Huron Medical Center

Port Huron, Michigan, 48060, United States

Location

Great Lakes Cancer Management Specialists-Rochester Hills

Rochester Hills, Michigan, 48309, United States

Location

Saint Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604, United States

Location

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, 48312, United States

Location

Great Lakes Cancer Management Specialists-Macomb Professional Building

Warren, Michigan, 48093, United States

Location

Macomb Hematology Oncology PC

Warren, Michigan, 48093, United States

Location

Michigan Breast Specialists-Warren

Warren, Michigan, 48093, United States

Location

Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661, United States

Location

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States

Location

IHA Hematology Oncology Consultants-Ann Arbor

Ypsilanti, Michigan, 48197, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, 63628, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Southeast Cancer Center

Cape Girardeau, Missouri, 63703, United States

Location

Capital Region Medical Center-Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States

Location

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

Location

Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, 63127, United States

Location

Community Hospital of Anaconda

Anaconda, Montana, 59711, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Saint Vincent Healthcare

Billings, Montana, 59101, United States

Location

Frontier Cancer Center and Blood Institute-Billings

Billings, Montana, 59102, United States

Location

Montana Cancer Consortium NCORP

Billings, Montana, 59102, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States

Location

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Saint Peter's Community Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Montana Cancer Specialists

Missoula, Montana, 59802, United States

Location

Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802, United States

Location

Community Medical Hospital

Missoula, Montana, 59804, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328, United States

Location

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534, United States

Location

Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States

Location

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546, United States

Location

Southeastern Medical Oncology Center-Wilson

Wilson, North Carolina, 27893, United States

Location

Southeast Clinical Oncology Research (SCOR) Consortium NCORP

Winston-Salem, North Carolina, 27104, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Saint Alphonsus Medical Center-Baker City

Baker City, Oregon, 97814, United States

Location

Saint Alphonsus Medical Center-Ontario

Ontario, Oregon, 97914, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

Location

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

Location

Baylor Saint Luke's Medical Center

Houston, Texas, 77030, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Cancer Care Center at Island Hospital

Anacortes, Washington, 98221, United States

Location

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225, United States

Location

Harrison HealthPartners Hematology and Oncology-Bremerton

Bremerton, Washington, 98310, United States

Location

Highline Medical Center-Main Campus

Burien, Washington, 98166, United States

Location

Swedish Medical Center-Edmonds

Edmonds, Washington, 98026, United States

Location

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Seattle Cancer Care Alliance at EvergreenHealth

Kirkland, Washington, 98034, United States

Location

Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States

Location

Harrison HealthPartners Hematology and Oncology-Poulsbo

Poulsbo, Washington, 98370, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical PLLC

Seattle, Washington, 98104, United States

Location

Swedish Medical Center-Ballard Campus

Seattle, Washington, 98107, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Group Health Cooperative-Seattle

Seattle, Washington, 98112, United States

Location

Swedish Medical Center-First Hill

Seattle, Washington, 98122-4307, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

United General Hospital

Sedro-Woolley, Washington, 98284, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Evergreen Hematology and Oncology PS

Spokane, Washington, 99218, United States

Location

Rockwood Clinic

Spokane, Washington, 99220, United States

Location

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801, United States

Location

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Rocky Mountain Oncology

Casper, Wyoming, 82609, United States

Location

Big Horn Basin Cancer Center

Cody, Wyoming, 82414, United States

Location

Billings Clinic-Cody

Cody, Wyoming, 82414, United States

Location

Welch Cancer Center

Sheridan, Wyoming, 82801, United States

Location

Related Publications (1)

• Statler A, Othus M, Erba HP, Chauncey TR, Radich JP, Coutre S, Advani A, Nand S, Ravandi F, Mukherjee S, Sekeres MA. Comparable outcomes of patients eligible vs ineligible for SWOG leukemia studies. Blood. 2018 Jun 21;131(25):2782-2788. doi: 10.1182/blood-2018-01-826693. Epub 2018 Apr 4.

  PMID: 29618479 DERIVED

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Congenital Abnormalities

Interventions

Cytarabine; Idarubicin; Pravastatin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Naphthalenes

Results Point of Contact

• Title: S0919 Statistician
• Organization: SWOG Statistical Center

amoseley@fredhutch.org

2066674623

Study Officials

• Anjali Advani, MD

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2009
• First Posted: February 10, 2009
• Study Start: December 10, 2009
• Primary Completion: December 1, 2018
• Study Completion: October 21, 2021
• Last Updated: May 3, 2023
• Results First Posted: January 13, 2020

Record last verified: 2023-05

Locations

US (185)