A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

April 27, 2012

Primary Completion Date

May 19, 2015

Study Completion Date

May 15, 2018

Conditions
Acute Myeloid LeukemiaAcute Myelogenous Leukemia
Interventions
DRUG

Azacitidine

Azacitidine at 75 mg/m\^2/day subcutaneous on Days 1-7

DRUG

Lenalidomide

Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily

OTHER

Best Supportive Care (BSC)

"The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.~BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support"

Trial Locations (30)

29605

(205) Greenville Hospital System, Greenville

33140

(145) Mount Sinai Comprehensive Cancer Center, Miami Beach

37203

(230) Tennessee Oncology, PLLC, Nashville

40202

(175) University Lousiville, Louisville

53792

(135) University of Wisconsin, Madison

55455

(235) University of Minnesota, Minneapolis

57105

(120) Avera Cancer Institute, Sioux Falls

59101

(150) Billings Clinic, Billings

60612

(140) Rush University Medical Center, Chicago

66205

(185) The University of Kansas Cancer Center, Westwood

70072

(195) Tulane University Hospital Tulane Cancer Center, New Orleans

78229

(155) Cancer Care Centers of South Texas, San Antonio

80045

(115) University of Colorado Anschultz Cancer Center, Aurora

85724

(210) University of Arizona Cancer Center, Tucson

90048

(240) Cedars-Sinai Medical Center, Los Angeles

92868

(215) Hematology Oncology Medical Group, Orange

93401

(200) Coastal Integrative Cancer Care, San Luis Obispo

94305

(125) University of Stanford, Stanford

95857

(130) UC Davis Medical Center, Sacramento

92093-0960

(180) University of California, San Diego, La Jolla

63110-1093

(100) Washington University School of Medicine, St Louis

10029-65749

(165) Mount Sinai Medical Center New York, New York

15224-1791

(160) The Western Pennsylvania Hospital- Cancer Institute, Pittsburgh

75390-9179

(105) University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center, Dallas

T2N 4N2

(402) Tom Baker Cancer Centre, Calgary

T6G 1Z1

(405) University of Alberta Hospital, Edmonton

R3E 0V9

(401) Cancer Care Manitoba, Winnipeg

B3H 2Y9

(403) Queen Elizabeth II Health Sciences Centre - VG Site, Halifax

K1H 8L6

(404) The Ottawa Hospital, Ottawa

M5G 2M9

(400) Princess Margaret Hospital, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT01358734 - A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter