S9920 Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

February 29, 2000

Primary Completion Date

March 31, 2004

Study Completion Date

March 31, 2006

Conditions
LeukemiaMyelodysplastic Syndromes
Interventions
DRUG

busulfan

arm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4

DRUG

cyclophosphamide

arm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4

DRUG

cyclosporine

both arms per published schedule

DRUG

methotrexate

GVHD: 15 mg/m2 day 1, 10 mg/m2 day 3, 6 and 11 by IV

PROCEDURE

allogeneic bone marrow transplantation

day 0

RADIATION

radiation therapy

both arms: 1200 cGy total dose (6 x 200 fractions)

Trial Locations (66)

10032

Herbert Irving Comprehensive Cancer Center, New York

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

45236

Jewish Hospital of Cincinnati, Inc., Cincinnati

45409

Miami Valley Hospital, Dayton

45429

CCOP - Dayton, Kettering

48202

Henry Ford Hospital, Detroit

60153

Loyola University Medical Center, Maywood

65804

St. John's Health System, Springfield

65807

CCOP - Cancer Research for the Ozarks, Springfield

67214

Cancer Center of Kansas - Wichita, Wichita

70112

MBCCOP - LSU Health Sciences Center, New Orleans

Tulane University School of Medicine, New Orleans

70115

Memorial Medical Center, New Orleans

72205

University of Arkansas for Medical Sciences, Little Rock

73190

University of Oklahoma Health Sciences Center, Oklahoma City

76508

CCOP - Scott and White Hospital, Temple

Scott and White Clinic, Temple

78229

Methodist Health Care System, San Antonio

78234

Brooke Army Medical Center, Fort Sam Houston

79423

Texas Tech University Health Science Center, Lubbock

79430

Health Science Center, Lubbock

80010

University of Colorado Cancer Center, Denver

83712

Mountain States Tumor Institute, Boise

84112

Huntsman Cancer Institute, Salt Lake City

84143

LDS Hospital, Salt Lake City

85724

Arizona Cancer Center, Tucson

92037

Scripps Clinic, La Jolla

92868

Chao Family Comprehensive Cancer Center, Orange

94598

Northern California Cancer Specialists Medical Clinic, Walnut Creek

94704

Alta Bates Comprehensive Cancer Center, Berkeley

95816

Sutter Cancer Center, Sacramento

95817

University of California Davis Cancer Center, Sacramento

96813

Cancer Research Center of Hawaii, Honolulu

Queen's Medical Center, Honolulu

96817

St. Francis Medical Center, Honolulu

97210

Legacy Cancer Services, Portland

97213

CCOP - Columbia River Program, Portland

97225

Providence St. Vincent Medical Center, Portland

98101

CCOP - Virginia Mason Research Center, Seattle

98104

Swedish Cancer Institute, Seattle

85062-2989

Good Samaritan Medical Center, Phoenix

91010-3000

Cancer Center and Beckman Research Institute, City of Hope, Duarte

90033-0804

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

90095-1781

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles

92613-5600

St. Joseph Hospital - Orange, Orange

94305-5408

Stanford University Medical Center, Stanford

66160-7357

University of Kansas Medical Center, Kansas City

67214-3882

CCOP - Wichita, Wichita

40536-0084

Albert B. Chandler Medical Center, University of Kentucky, Lexington

40536-0093

Lucille Parker Markey Cancer Center, University of Kentucky, Lexington

70112-2822

Louisiana State University School of Medicine, New Orleans

71130-3932

Louisiana State University Health Sciences Center - Shreveport, Shreveport

02118

Boston Medical Center, Boston

Cancer Research Center, Boston

48109-0752

University of Michigan Comprehensive Cancer Center, Ann Arbor

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

39216-4505

University of Mississippi Medical Center, Jackson

63110-0250

St. Louis University Health Sciences Center, St Louis

97201-3098

Oregon Cancer Center, Portland

78236-5300

Wilford Hall - 59th Medical Wing, Lackland Air Force Base

78284-7811

University of Texas Health Science Center at San Antonio, San Antonio

98109-1024

Fred Hutchinson Cancer Research Center, Seattle

98195-6043

University of Washington Medical Center, Seattle

98401-2197

Franciscan Health System, Tacoma

98405-0986

CCOP - Northwest, Tacoma

M5G 2M9

Princess Margaret Hospital, Toronto

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

SWOG Cancer Research Network

NETWORK

NCT00005866 - S9920 Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter