AzTrials
AzTrials

Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromePhase 3NCT00093470

Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

A Phase 3 study testing Clinical Observation and Tipifarnib in people with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Adult Acute Megakaryoblastic Leukemia, run by National Cancer Institute (NCI) at 341 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized phase III trial studies tipifarnib in treating patients with acute myeloid leukemia (AML) in remission. Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Clinical Observation and Tipifarnib
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
341 sitesin 3 countries
Study dates
18 Aug 2004to 14 Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients eligible to enter this study must fall into one of these categories:
  • Patients in first remission following primary induction failure
  • Patients must have received at least two chemotherapy induction regimens
  • Patients in second or subsequent remission
  • Patients > 60 years old in first remission
  • Patients must be in complete remission (CR) or morphologic remission (MR) by blood counts and bone marrow studies to enter the study
Show all 41Show fewer
  • Confirmatory bone marrow must be performed =< 2 weeks prior to randomization
  • Patients must have morphologic proof (from bone marrow aspirate, smears or touch preps of marrow biopsy) that they had AML of one of the following types prior to achievement of CR/MR
  • Acute myeloblastic leukemia, minimal differentiation (French-American-British [FAB] M0)
  • Acute myeloblastic leukemia without differentiation (FAB M1)
  • Acute myeloblastic leukemia with maturation (FAB M2)
  • Acute myelomonocytic leukemia (FAB M4)
  • Acute monocytic leukemia (FAB M5)
  • Acute erythroleukemia (FAB M6)
  • Acute megakaryocytic leukemia (FAB M7)
  • Refractory anemia with excess blasts in transformation (RAEB-T)
  • AML by World Health Organization (WHO) criteria
  • Acute myeloid leukemia with multilineage dysplasia
  • Patients with acute promyelocytic leukemia (FAB M3) are not eligible
  • Patients must be registered within 60 days of completion of therapy for the current remission; patients are eligible if they meet any of the criteria below:
  • Within 60 days of remission (CR or MR) by peripheral blood counts following induction therapy or
  • Within 60 days of discharge from the hospital following induction therapy or
  • Within 60 days of discharge from the hospital following post-remission therapy or
  • Within 60 days of recovery of blood counts following last dose of chemotherapy
  • All of the patients below are eligible for study entry:
  • Patients who have received consolidation therapy
  • Patients who have not received any consolidation or post remission therapy
  • Patients who have had an autologous stem cell transplant
  • Patients who have received an allogeneic transplant (bone marrow transplant [BMT] or peripheral stem cell transplant [PSCT]) in their current remission are ineligible; patients who have had an allogeneic transplant in a previous remission and are currently in remission after subsequent relapse are eligible
  • Patients with a history of extramedullary disease are eligible if they are in complete remission at the time of study entry and no longer requiring therapy for their extramedullary disease
  • Patients must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study < 2 weeks prior to randomization to rule out pregnancy
  • Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
  • Patients must not be known to have an allergy to imidazole drugs, such as clotrimazole ketoconazole, miconazole, econazole, or terconazole; this does not include fluconazole, voriconazole, or itraconazole
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
  • Patients must not have active cardiac or pulmonary disease; but patient will be eligible if disease is medically controlled
  • Patients must not have active renal disease; creatinine must be =< 1.5 x upper limit of normal
  • Patients must not have active hepatic disease; total or direct bilirubin must be < 2 mg/dl
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) must be =< 2.5 times the upper limit of normal
  • Absolute neutrophil count (ANC) >= 1000/mm^3
  • Platelet count >= 50,000/mm^3
  • Patients must not be taking a hepatic enzyme-inducing anti-convulsant; a patient will not be eligible for the study if the patient is currently taking one of these agents and cannot be switched to a non-hepatic enzyme-inducing anti-convulsant

Who cannot join

None listed.

Trial locations and contacts

341 sites in 3 countries.

302 sites in 3 countries

United States300 sites

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Medini, Eitan MD (UIA Investigator)

    Alexandria, Minnesota, 56308

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Memorial Hospital of Arkansas City

    Arkansas City, Kansas, 67005

  • University Cancer and Blood Center LLC

    Athens, Georgia, 30607

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Ochsner Health Center-Summa

    Baton Rouge, Louisiana, 70809

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Deaconess Medical Center

    Billings, Montana, 59107

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Internal Medicine of Bozeman

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • Jesse Brown Veterans Affairs Medical Center

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Mercy Hospital and Medical Center

    Chicago, Illinois, 60616

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • The Jewish Hospital

    Cincinnati, Ohio, 45236

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Genesis Medical Center - West Campus

    Davenport, Iowa, 52804

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Cancer Research Program NCORP

    Denver, Colorado, 80222

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Eureka Hospital

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Etzell, Paul S MD (UIA Investigator)

    Fergus Falls, Minnesota, 56537

  • Swenson, Wade II, MD (UIA Investigator)

    Fergus Falls, Minnesota, 56537

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Unity Hospital

    Fridley, Minnesota, 55432

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Franklin Medical Center

    Greenfield, Massachusetts, 01301

  • Hattiesburg Clinic - Hematology/Oncology Clinic

    Hattiesburg, Mississippi, 39401

  • Hematology and Oncology Clinic

    Hattiesburg, Mississippi, 39402

  • Mason District Hospital

    Havana, Illinois, 62644

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Hinsdale Hematology Oncology Associates Incorporated

    Hinsdale, Illinois, 60521

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois, 61747

  • Mary Bird Perkins Cancer Center/Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

  • Baylor Saint Luke's Medical Center

    Houston, Texas, 77030

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Michael E DeBakey VA Medical Center

    Houston, Texas, 77030

  • The Methodist Hospital System

    Houston, Texas, 77030

  • Hematology Oncology Associates of Eastern Idaho

    Idaho Falls, Idaho, 83404

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Midwest Center for Hematology Oncology

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Kalamazoo Center for Medical Studies

    Kalamazoo, Michigan, 49008

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Kinston Medical Specialists PA

    Kinston, North Carolina, 28501

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Deerpath Medical Associates

    Lake Forest, Illinois, 60045

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Liberty Radiation Oncology Center

    Liberty, Missouri, 64068

  • NorthShore Hematology Oncology-Libertyville

    Libertyville, Illinois, 60048

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Marshfield Medical Center

    Marshfield, Wisconsin, 54449

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Orange Regional Medical Center

    Middletown, New York, 10940

  • Eastern Montana Cancer Center

    Miles City, Montana, 59301

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98274

  • The Community Hospital

    Munster, Indiana, 46321

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Illinois Cancer Specialists-Niles

    Niles, Illinois, 60714

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73120

  • Franciscan St. James Health-Olympia Fields Campus

    Olympia Fields, Illinois, 60461

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Cancer Center of Kansas - Ottawa

    Ottawa, Kansas, 66067

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Kansas City NCI Community Oncology Research Program

    Prairie Village, Kansas, 66208

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Ascension Saint Mary's Hospital

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic-Rice Lake Center

    Rice Lake, Wisconsin, 54868

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Sarah Culbertson Memorial Hospital

    Rushville, Illinois, 62681

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64507

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Intermountain Health Care

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Kaiser Permanente-San Diego Mission

    San Diego, California, 92108

  • Memorial University Medical Center

    Savannah, Georgia, 31404

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Mercy Hospital

    Scranton, Pennsylvania, 18501

  • Scranton Hematology Oncology

    Scranton, Pennsylvania, 18510

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical PLLC

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Kaiser Permanente Washington

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • PeaceHealth United General Medical Center

    Sedro-Woolley, Washington, 98284

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Shawnee Mission Medical Center-KCCC

    Shawnee Mission, Kansas, 66204

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Overton Brooks Veteran's Administration Medical Center

    Shreveport, Louisiana, 71101

  • Louisiana State University Health Sciences Center Shreveport

    Shreveport, Louisiana, 71103

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51104

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Avera McKennan Hospital and University Health Center

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center

    Sioux Falls, South Dakota, 57105

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Edward H Kaplan MD and Associates

    Skokie, Illinois, 60076

  • Hematology Oncology Associates of Illinois - Skokie

    Skokie, Illinois, 60076

  • Midwest Cancer Research Group Incorporated

    Skokie, Illinois, 60077

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Providence Hospital-Southfield Cancer Center

    Southfield, Michigan, 48075

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

Other trials in United States

Israel1 site

  • Rambam Medical Center

    Haifa, 31096

Other trials in Israel

Peru1 site

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34

Other trials in Peru

About this study

Official title: A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure or Patients Over Age 60 in First Remission

This randomized phase III trial studies tipifarnib in treating patients with acute myeloid leukemia (AML) in remission. Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether tipifarnib is more effective than observation alone in preventing the recurrence of AML.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare R115777 (tipifarnib) maintenance therapy to observation only with respect to disease-free survival (DFS) in patients with AML in second or subsequent complete remission or in complete response (CR) following primary induction failure.

SECONDARY OBJECTIVES:

  1. To compare overall survival of patients in both arms. II. To evaluate the long-term safety and toxicity of extended administration of R115777 in AML patients in remission.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo observation only.

After completion of study treatment, patients are followed up for 5 years.

Being tested
Clinical Observation, Tipifarnib
Medical subject headings
Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Myeloid, Acute, Leukemia, Erythroblastic, Acute, Anemia, Refractory, with Excess of Blasts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical ObservationProcedure or surgery

    Also called observation

    Undergo observation

  • TipifarnibDrug

    Also called R115777, Zarnestra

    Given PO

Study groups in NCT00093470
Study groupRoleWhat they receive
Arm A (tipifarnib)ExperimentalPatients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Tipifarnib
Arm B (clinical observation)OtherPatients undergo observation only.
Receives: Procedure: Clinical Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival

    Disease-free survival (DFS) is defined as the time from randomization to relapse or death without relapse.

    Measured: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.

Secondary outcomes (1)

  1. Overall Survival

    Overall survival (OS) is defined as the time from randomization to death from any cause.

    Measured: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2004 (estimated)
  2. Study start18 Aug 2004
  3. Primary completion20 Feb 2015
  4. Study completion14 Apr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00093470
Sponsor's protocol ID
NCI-2009-00535
Other IDs
NCI-2009-00535, E2902, E2902, E2902, U10CA180820, U10CA021115
Status last verified
Jun 2026
First submitted
6 Oct 2004
Last updated
14 Jul 2026
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clinical Observation and Tipifarnib in people with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Adult Acute Megakaryoblastic Leukemia, run by National Cancer Institute (NCI) at 341 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 341 sites in United States, Israel, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (time frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00093470.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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