AzTrials
AzTrials

AnemiaPhase 3NCT00843882

Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia

A Phase 3 study testing Bone Marrow Biopsy, Epoetin Alfa and Laboratory Biomarker Analysis in people with Anemia and Chronic Myelomonocytic Leukemia, run by National Cancer Institute (NCI) at 507 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bone Marrow Biopsy, Epoetin Alfa and Laboratory Biomarker Analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
247 participants
Where
507 sitesUnited States
Study dates
20 Apr 2009to 28 May 2027
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

  • Age >= 18 years
  • NOTE: Results of the bone marrow biopsy and aspirate as well as cytogenetics are mandatory to register subjects onto study, which are indispensable to determine International Prognostic Scoring System (IPSS) category needed for eligibility; please note that it is not necessary to wait for the week 16, week 32, or week bone marrow and cytogenetic results prior to starting the next cycle unless deemed necessary by the treating physician; one example of this exception can include if the subject shows signs of progression, such as increased peripheral blood blast percentage; at that juncture, the treating physician may prefer to await the results prior to starting a new cycle; if a cycle is started, and based on the bone marrow results it is felt by the treating physician that the subject should not continue on treatment, please be sure to note this information on the case report forms at end of treatment
  • Patient must have documented diagnosis of MDS lasting at least three months (MDS duration >= 3 months) according to World Health Organization (WHO) criteria or non-proliferative chronic myelomonocytic leukemia (CMML) (white blood cell [WBC] < 12,000/mcL)
  • Patient must have International Prognostic Scoring System (IPSS) categories of low- or intermediate-1-risk disease; patients must have IPSS score determined by cytogenetic analysis prior to randomization; patients must have cytogenetic analysis done (to calculate IPSS); if the current bone marrow biopsy is a dry tap, patients with cytogenetic failure and < 10% marrow blasts will be eligible; subjects with cytogenetic failure must have previous cytogenetic results (fluorescence in situ hybridization [FISH] is not a substitute) within the last 6 months post last type of MDS treatment (in this case, not referring to growth factors as type of MDS treatment)
  • Must have symptomatic anemia untransfused with hemoglobin < 9.5 g/dL =< 8 weeks prior to randomization or with red blood cells (RBC) transfusion dependence (i.e., >= 2 units/month) confirmed for =< 8 weeks before randomization
  • NOTE: For non-transfusion dependent patients (i.e., receiving < 2 units/4 weeks x 8 weeks pre-study) who receive periodic transfusions, the mean 8 week pre-transfusion hemoglobin should be used to determine protocol eligibility and response reference
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  • For non-transfusion dependent patients, a minimum of 2 pre-transfusion or un-transfused hemoglobin values are required
  • Applies only for patients without the deletion 5q 31.1; patients must have failed treatment with an erythropoietic growth factor, or have a low probability of response to rhu-erythropoietin; patients with low probability of response to rhu-erythropoietin or prior erythropoietin failures are defined as follows:
  • Prior erythropoietin failure-requires a minimum trial of >= 40,000 units epoetin alfa/week x 8 weeks or equivalent dose of darbepoetin alfa for 8 weeks with failure to achieve transfusion independence in dependent patients or a failure to achieve a >= 2 g rise in hemoglobin sustained for >= 4 weeks in non-transfusion dependent patients
  • Low erythropoietin response profile-rhu-erythropoietin and epoetin alfa-naïve patients receiving >= 2U packed (p)RBC/month for a minimum of 8 weeks, and serum erythropoietin > 500 mU/mL in the 8 weeks prior to randomization for a hemoglobin < 9.5 g/dL
  • Patients must be off all non-transfusion therapy for MDS for 28 days prior to initiation of study treatment, including all types of growth factors; patients may receive hydrocortisone prophylactically to prevent transfusion reactions
  • Patients must have a serum erythropoietin level documented before randomization and =< 56 days before day 1 of study treatment; NOTE: hemoglobin must be < 9.5 g/dL at time that serum erythropoietin is drawn
  • Effective contraception must be used by patients participating in lenalidomide therapy, and all patients must agree to counseling by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure; females of childbearing potential (FCBP) must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide, during lenalidomide therapy, during dose interruptions, and for at least 28 days following discontinuation of lenalidomide therapy; females of childbearing potential should be referred to a qualified provider of contraceptive methods, if needed; males receiving lenalidomide must agree to use a latex condom during any sexual contact with females of childbearing potential even if they have undergone a successful vasectomy
  • Platelet count >= 50,000/mcL (50 x 10^9/L) without platelet transfusion (within 56 days prior to randomization)
  • Absolute neutrophil count (ANC) >= 500 cells/mcL (0.5 x 10^9/L); hence ANC must be >= 500/mcL without myeloid growth factor support (within 56 days prior to randomization)
  • Serum creatinine =< 1.5 times upper limit of normal (ULN) (within 56 days prior to randomization)
  • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =< 2.0 x ULN (within 56 days prior to randomization)
  • Serum total bilirubin < 3.0 mg/dL (within 56 days prior to randomization)
  • Inclusion criteria for crossover registration from Arm A (lenalidomide alone) to Arm B (lenalidomide and epoetin alfa):
  • Patients must have completed 16 weeks of monotherapy with lenalidomide
  • Patients must show failure to achieve MER (major erythroid response) or have achieved MER but relapsed on Arm A

Who cannot join

  • Patients must not have documented iron deficiency; all patients must have documented marrow iron stores; if marrow iron stain is not available, the transferrin saturation must be > 20% or a serum ferritin > 100 ng/mL
  • Women must not be pregnant or breastfeeding; females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; a female of childbearing potential (FCBP) is any woman, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months; FCBP must also agree to ongoing pregnancy testing)
  • Patients must not have prior therapy with lenalidomide
  • Patients must not have a diagnosis of uncontrolled seizure or uncontrolled hypertension
  • Patients must not have proliferative (WBC >= 12,000/mcL) chronic myelomonocytic leukemia (CMML); WBC must be < 12,000/mcL
  • Patients must not have MDS secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases
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  • Prior thalidomide therapy is allowed, however, patients must not have prior >= grade-3 allergic reactions to thalidomide
  • Patients must not have prior history of desquamating rash from thalidomide at time of study entry
  • Patients must not have clinically significant anemia resulting from iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding
  • Patients must not have used cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 8 weeks of randomization
  • Patients must not have prior history of malignancy other than MDS (except basal cell or squamous skin cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been confirmed free of disease for >= 3 years
  • Patients must not have any serious medical condition or any other unstable medical co-morbidity, or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study
  • Patients must not have a history of thrombo-embolic events within 3 years prior to study randomization
  • Patients must not have known human immunodeficiency virus (HIV)-1 seropositivity because HIV can be an alternate cause of anemia.
  • Patients must not have a known allergic reaction to epoetin alfa (Procrit) or human serum albumin
  • Exclusion criteria for crossover registration from Arm A (lenalidomide alone) to Arm B (lenalidomide and epoetin alfa):
  • Patients must not have a limiting unresolved grade 3 or greater toxicity from lenalidomide monotherapy or drug intolerance preventing continuation of lenalidomide treatment

Trial locations and contacts

507 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Medini, Eitan MD (UIA Investigator)

    Alexandria, Minnesota, 56308

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Mission Hospital

    Asheville, North Carolina, 28801

  • King's Daughter's Medical Center

    Ashland, Kentucky, 41101

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • CommonSpirit Saint Joseph Hospital - Bardstown

    Bardstown, Kentucky, 40004

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • 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

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Dana-Farber Cancer Institute at Boston Medical Center - Brighton

    Brighton, Massachusetts, 02135

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Butler Memorial Hospital

    Butler, Pennsylvania, 16001

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Vandalia Health/CAMC Institute for Academic Medicine

    Charleston, West Virginia, 25304

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • Presence Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

  • North Coast Cancer Care-Clyde

    Clyde, Ohio, 43410

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio, 45459

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • AdventHealth Porter

    Denver, Colorado, 80210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western States Cancer Research 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

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Veterans Adminstration New Jersey Health Care System

    East Orange, New Jersey, 07018-1095

  • 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

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Ephrata Community Hospital

    Ephrata, Pennsylvania, 17522

  • OSF Saint Francis Hospital and Medical Group

    Escanaba, Michigan, 49829

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Saint Francis Hospital

    Evanston, Illinois, 60202

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • University of Connecticut

    Farmington, Connecticut, 06030

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Nebraska Cancer Specialists/Oncology Hematology West PC

    Grand Island, Nebraska, 68803

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29601

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Rocky Mountain Cancer Centers-Greenwood Village

    Greenwood Village, Colorado, 80111

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • WellSpan Medical Oncology and Hematology

    Hanover, Pennsylvania, 17331

  • Kaiser Permanente South Bay

    Harbor City, California, 90710

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Hematology Oncology Associates of Illinois-Highland Park

    Highland Park, Illinois, 60035

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • IU Health Central Indiana Cancer Centers-East

    Indianapolis, Indiana, 46219

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Allegiance Health

    Jackson, Michigan, 49201

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • Mercyhealth Hospital and Cancer Center - Janesville

    Janesville, Wisconsin, 53548

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • University of Wisconsin Carbone Cancer Center - Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • Midwest Center for Hematology Oncology

    Joliet, Illinois, 60432

  • Duly Health and Care Joliet

    Joliet, Illinois, 60435

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • Presence Saint Mary's Hospital

    Kankakee, Illinois, 60901

  • University Health 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

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • Research Medical Center

    Kansas City, Missouri, 64132

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Cheshire Medical Center-Dartmouth-Hitchcock Keene

    Keene, New Hampshire, 03431

  • Keesler Medical Center

    Keesler Air Force Base, Mississippi, 39534

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • EvergreenHealth Medical Center

    Kirkland, Washington, 98033

  • Covenant Health Cancer Centers

    Knoxville, Tennessee, 37916

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • IU Health Arnett Cancer Care

    Lafayette, Indiana, 47904

  • CommonSpirit Saint Anthony Hospital Cancer Center

    Lakewood, Colorado, 80228

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Nevada Cancer Research Foundation NCORP

    Las Vegas, Nevada, 89120

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89183

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Leesburg Regional Medical Center

    Leesburg, Florida, 34748

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Liberty Hospital

    Liberty, Missouri, 64068

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • AdventHealth Littleton

    Littleton, Colorado, 80122

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • SSM Health Dean Medical Group - South Madison Campus

    Madison, Wisconsin, 53715

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • UP Health System Marquette

    Marquette, Michigan, 49855

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Marshfield Medical Center

    Marshfield, Wisconsin, 54449

  • Sovah Health Martinsville

    Martinsville, Virginia, 24112

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Saint Luke's Hospital

    Maumee, Ohio, 43537

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

    Maumee, Ohio, 43537

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Premier Oncology Hematology Associates

    Merrillville, Indiana, 46410

  • Holy Family Hospital

    Methuen, Massachusetts, 01844

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

    Miami, Florida, 33136

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Garnet Health Medical Center

    Middletown, New York, 10940

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

Other trials in United States

About this study

Official title: Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment With Lenalidomide (Revlimid) Alone and in Combination With Epoetin Alfa (Procrit) in Subjects With Low- or Intermediate-1 Risk MDS and Symptomatic Anemia

This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare the rate of major erythroid response (MER) between lenalidomide monotherapy and combined treatment of lenalidomide and epoetin alfa in erythropoietin non-responsive low-/intermediate-1 (Int-1)-risk myelodysplastic syndrome (MDS) patients or erythropoietin treatment naïve patients with low probability of erythropoietin benefit.

SECONDARY OBJECTIVES:

  1. To compare the time to MER by treatment assignment. II. To evaluate the duration of MER by treatment assignment. III. To estimate the frequency of MER to salvage combination therapy in patients who fail to experience a MER with lenalidomide monotherapy.

IV. To evaluate and compare the frequency of minor erythroid response by treatment assignment.

  1. To investigate the mechanism and target of lenalidomide action in patients with chromosome 5q31.1 deletion.

VI. To evaluate the frequency of cytogenetic response and progression, and the relation between cytogenetic pattern and erythroid response.

VII. To evaluate the frequency of bone marrow response (complete response [CR] + partial response [PR]).

VIII. To evaluate the relationship between erythroid response and laboratory correlates outlined below:

VIIIa. Pretreatment and on study endogenous erythropoietin level (Arm A). VIIIb. To evaluate the effect of CD45 isoform profile on lenalidomide enhancement of erythropoietin-induced STAT5 phosphorylation in CD71^Hi erythroid precursors and the relationship to erythroid response.

VIIIc. To characterize molecular targets relevant to lenalidomide cytotoxicity in del5q31.1 cells.

VIIId. To evaluate the frequency of cryptic chromosome 5q31.1 deletions in patients with non-del5q31.1 MDS by array-based genomic scan, and to determine the relationship to hematologic response.

OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with del 5q31.1 karyotype are assigned to Arm A.

ARM A: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study.

ARM B: Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa subcutaneously (SC) once weekly. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study.

In both arms, treatment repeats every 28 days for 4 cycles. Patients who achieve a major erythroid response (MER) may continue treatment beyond 4 cycles in the absence of disease progression, disease conversion to acute myeloid leukemia, or unacceptable toxicity. Patients in Arm A who fail to achieve MER or who achieve MER but relapse after 16 weeks of treatment with lenalidomide may crossover and receive treatment in Arm B.

After completion of study treatment, patients are followed up for 6 months.

Being tested
Bone Marrow Biopsy, Epoetin Alfa, Laboratory Biomarker Analysis, Lenalidomide
Medical subject headings
Anemia, Leukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes

What participants receive

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

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Epoetin AlfaBiological

    Also called EPO, Epoetin alfa-epbx, Epogen, Eprex

    Given SC

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • LenalidomideDrug

    Also called CC 5013, CC-5013, CC5013, CDC 501

    Given PO

Study groups in NCT00843882
Study groupRoleWhat they receive
Arm A (lenalidomide)Active comparatorPatients receive lenalidomide PO QD on days 1-21. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study.
Receives: Procedure: Bone Marrow Biopsy; Other: Laboratory Biomarker Analysis; Drug: Lenalidomide
Arm B (lenalidomide, epoetin alfa)ExperimentalPatients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study.
Receives: Procedure: Bone Marrow Biopsy; Biological: Epoetin Alfa; Other: Laboratory Biomarker Analysis; Drug: Lenalidomide

What is being measured

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

  1. Proportion of Patients With Major Erythroid Response (MER)

    Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a > 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.

    Measured: Assessed after completion of 16 weeks of treatment

Secondary outcomes (9)

  1. Time to Major Erythroid Response (MER)

    Time to major erythroid response (MER) is defined in responders as the time from randomization to the documented date of MER.

    For transfusion independent patients, the date of MER is the first date of the elevation in hemoglobin level of more than 2 g/dL that has been sustained for at least 8 weeks. For transfusion dependent patients, the date of MER is the beginning date of the time interval of transfusion independence that has been sustained for at least eight weeks.

    Measured: Assessed every cycle during treatment and then 3 and 6 months after last protocol treatment

  2. Duration of Major Erythroid Response (MER)

    Duration of major erythroid response (MER) is defined as the time interval between the documented date of MER and the earliest date of resumption of red blood cell transfusions ≥ 2 units in an 8-week period, a reduction in hemoglobin concentration ≥ 2 g/dL in the absence of acute infection, gastrointestinal bleeding and hemolysis, or death.

    Measured: Assessed every cycle during treatment and then 3 and 6 months after last protocol treatment

  3. Proportion of Patients With Major Erythroid Response (MER) to Salvage Combination Therapy

    Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a > 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.

    Measured: Assessed after completion of 16 weeks of treatment

  4. Proportion of Patients With Minor Erythroid Response

    The definition of minor erythroid response: the mean hemoglobin is sustained 1.0 to 2.0 g/dL above the baseline value for a minimum of 8 weeks; or a 50% or greater decrease in 8-week red blood cell transfusion requirements compared to baseline.

    Measured: Assessed every cycle during treatment and after completion of 16 weeks of treatment

  5. Proportion of Patients With Major Erythroid Response (MER) Among Those With Chromosome 5q31.1 Deletion

    Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a > 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.

    Measured: Assessed after completion of 16 weeks of treatment

  6. Proportion of Patients With Bone Marrow Response

    Bone marrow response includes complete remission (CR) and partial remission (PR).

    Complete remission (CR): Bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. When erythroid precursors constitute < 50% of bone marrow nucleated cells, the percent of blasts is based on all nucleated cells; when there are ≥ 50% erythroid cells, the percent blasts should be based on the non-erythroid cells.

    Partial remission (PR): All of the CR criteria (if abnormal prior to treatment), except blasts decreased by 50% over pre-treatment, or a less advanced Myelodysplastic Syndromes (MDS) World Health Organization (WHO) classification than pretreatment. Cellularity and morphology are not relevant.

    Measured: Assessed at 16 weeks

  7. Proportion of Patients With Cytogenetic Response

    Evaluation of cytogenetic response requires 20 analyzable metaphases when using conventional techniques. Analysis of data will require 20 metaphases before and after treatment, which must be done on bone marrow only (peripheral blood is not a substitute). Fluorescent in situ hybridization (FISH) may be used as a supplement to follow a specifically defined cytogenetic abnormality, but it is not a substitute for conventional cytogenetic studies. Cytogenetic response is defined as follows: Complete response: Restoration of a normal karyotype in patients with a documented pre-existing clonal (>2 metaphases abnormal) chromosome abnormalities.

    Partial response: > 50% reduction in the percentage of bone marrow metaphases with only clonal abnormality.

    Measured: Assessed at baseline and after completion of 16 weeks of treatment

  8. Association Between Major Erythroid Response and Cytogenetic Response

    Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a > 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.

    Evaluation of cytogenetic response requires 20 analyzable metaphases before and after treatment, which must be done on bone marrow only. Fluorescent in situ hybridization (FISH) may be used as a supplement to follow a specifically defined cytogenetic abnormality, but it is not a substitute for conventional cytogenetic studies. Cytogenetic response is defined as follows:

    Complete response: Restoration of a normal karyotype in patients with a documented pre-existing clonal (>2 metaphases abnormal) chromosome abnormalities.

    Partial response: > 50% reduction in the percentage of bone marrow metaphases with only clonal abnormality.

    Measured: Assessed at baseline and after completion of 16 weeks of treatment

  9. Pretreatment Endogenous Erythropoietin Level

    Pretreatment endogenous erythropoietin level was assessed at baseline. The association between pretreatment endogenous erythropoietin level and major erythroid response was evaluated among patients who received lenalidomide alone.

    Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a > 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.

    Measured: Assessed at baseline and after completion of 16 weeks of treatment

Timeline

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

  1. First posted13 Feb 2009 (estimated)
  2. Study start20 Apr 2009
  3. Primary completion8 Jul 2019
  4. Study completion28 May 2027 (estimated)

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
Crossover
Masking
None (open label)
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00843882
Sponsor's protocol ID
NCI-2009-01173
Other IDs
NCI-2009-01173, CDR0000634119, ECOG-E2905, 09-0095, E2905, E2905, E2905, U10CA021115
Status last verified
Jun 2026
First submitted
12 Feb 2009
Last updated
1 Oct 2026
Data monitoring committee
No

Publications

  • List AF, Sun Z, Verma A, Bennett JM, Komrokji RS, McGraw K, Maciejewski J, Altman JK, Cheema PS, Claxton DF, Luger SM, Mattison RJ, Wassenaar TR, Artz AS, Schiffer CA, Litzow MR, Tallman MS. Lenalidomide-Epoetin Alfa Versus Lenalidomide Monotherapy in Myelodysplastic Syndromes Refractory to Recombinant Erythropoietin. J Clin Oncol. 2021 Mar 20;39(9):1001-1009. doi: 10.1200/JCO.20.01691. Epub 2021 Jan 13.

    PubMed 33439748

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bone Marrow Biopsy, Epoetin Alfa and Laboratory Biomarker Analysis in people with Anemia and Chronic Myelomonocytic Leukemia, run by National Cancer Institute (NCI) at 507 sites in United States.

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 21 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 507 sites in United States. 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 8 Jul 2021). 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?

Proportion of Patients With Major Erythroid Response (MER) (time frame: Assessed after completion of 16 weeks of treatment). 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 NCT00843882, which also lists 1 linked publication.

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 1 Oct 2026.

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