Erythropoietin (EPO)+/- Filgrastim (G-CSF) vs. Supportive Therapy Alone for Patients With Myelodysplastic Syndromes

PHASE3CompletedINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

March 4, 1998

Primary Completion Date

August 31, 2008

Study Completion Date

May 31, 2014

Conditions
AnemiaMyelodysplastic Syndromes
Interventions
BIOLOGICAL

Erythropoietin

Administered at 150 units/kg subcutaneously every day. Rotating sites should be used. The dose should be rounded off to the nearest 1000 U. The dose should be adjusted based on hematocrit.

BIOLOGICAL

Filgrastim

G-CSF should start at a dose of 1 mcg/kg per day or 2.5 mcg/kg three times a week subcutaneously. Rotating sites should be used The dose should be rounded off to the nearest 10 mcg.

PROCEDURE

Transfusion

Red cell and platelet transfusions

Trial Locations (28)

10016

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York

43206

CCOP - Columbus, Columbus

44109

MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland

48106

CCOP - Michigan Cancer Research Consortium, Ann Arbor

49007

West Michigan Cancer Center, Kalamazoo

54449

CCOP - Marshfield Clinic Research Foundation, Marshfield

55416

CCOP - Metro-Minnesota, Saint Louis Park

57104

CCOP - Sioux Community Cancer Consortium, Sioux Falls

58122

CCOP - Merit Care Hospital, Fargo

60611

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago

61602

CCOP - Illinois Oncology Research Association, Peoria

61801

CCOP - Carle Cancer Center, Urbana

68106

CCOP - Missouri Valley Cancer Consortium, Omaha

70112

MBCCOP - LSU Health Sciences Center, New Orleans

76508

CCOP - Scott and White Hospital, Temple

80224

CCOP - Colorado Cancer Research Program, Incorporated, Denver

89106

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas

60611-4494

Veterans Affairs Medical Center - Lakeside Chicago, Chicago

52403-1206

CCOP - Cedar Rapids Oncology Project, Cedar Rapids

50309-1016

CCOP - Iowa Oncology Research Association, Des Moines

02111

Tufts - New England Medical Center, Boston

49007-3731

CCOP - Kalamazoo, Kalamazoo

07019

Veterans Affairs Medical Center - East Orange, East Orange

07601

CCOP - Northern New Jersey, Hackensack

08903

Cancer Institute of New Jersey, New Brunswick

17822-2001

CCOP - Geisinger Clinic and Medical Center, Danville

54307-3453

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay

53226-3596

Medical College of Wisconsin Cancer Center, Milwaukee

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Eastern Cooperative Oncology Group

NETWORK

NCT00003138 - Erythropoietin (EPO)+/- Filgrastim (G-CSF) vs. Supportive Therapy Alone for Patients With Myelodysplastic Syndromes | Biotech Hunter | Biotech Hunter