- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
A Phase III Randomized Study Comparing Busulfan-Total Body Irradiation Versus Cyclophosphamide-Total Body Irradiation Preparative Regimen in Patients With Advanced Myelodysplastic Syndrome (MDS) or MDS-Related Acute Myeloid Leukemia (AML) Undergoing HLA-Identical Sibling Peripheral Blood Stem Cell Transplantation, (A BMT Study)
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known if total-body irradiation plus peripheral stem cell transplantation is more effective with busulfan or with cyclophosphamide for myelodysplastic syndrome or acute myeloid leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of busulfan with that of cyclophosphamide in patients undergoing total-body irradiation plus peripheral stem cell transplantation for advanced myelodysplastic syndrome or related acute myeloid leukemia.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
OBJECTIVES: I. Compare event free survival after total body irradiation (TBI) plus busulfan versus TBI plus cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation in patients with advanced myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia. II. Determine the distribution of pharmacokinetic parameters for busulfan in those patients randomized to the busulfan treatment arm. III. Investigate the prognostic significance for event free survival of prior history of red cell transfusions, cytogenetic pattern, and of functional drug resistance at diagnosis in these patients. IV. Estimate the frequencies of cytogenetic and genetic changes during disease progression in these patients.
OUTLINE: This a randomized, multicenter study. Patients are stratified according to age (40 and under vs 41-55) and diagnosis and International Prognostic Scoring System (IPSS) risk group (myelodysplastic syndrome (MDS)/IPSS - intermediate 1 vs MDS/IPSS - intermediate 2 vs MDS/IPSS high risk vs MDS related acute myeloid leukemia). Patients are randomized to one of two treatment arms. Arm I: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 for a total of 16 doses. Arm II: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients receive total body irradiation (TBI) twice a day on days -3 to -1; peripheral blood stem cell transplantation from genotypically HLA identical sibling on day 0; cyclosporine IV every 12 hours on days -1 to 60, and then tapering in the absence of graft versus host disease; and methotrexate IV on days 1, 3, 6, and 11. Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study over 5 years.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Arizona
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Phoenix, Arizona, Förenta staterna, 85062-2989
- Good Samaritan Medical Center
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Tucson, Arizona, Förenta staterna, 85724
- Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- University of Arkansas for Medical Sciences
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California
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Berkeley, California, Förenta staterna, 94704
- Alta Bates Comprehensive Cancer Center
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Duarte, California, Förenta staterna, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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La Jolla, California, Förenta staterna, 92037
- Scripps Clinic
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Los Angeles, California, Förenta staterna, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Förenta staterna, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Orange, California, Förenta staterna, 92868
- Chao Family Comprehensive Cancer Center
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Orange, California, Förenta staterna, 92613-5600
- St. Joseph Hospital - Orange
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Sacramento, California, Förenta staterna, 95816
- Sutter Cancer center
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Sacramento, California, Förenta staterna, 95817
- University of California Davis Cancer Center
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Stanford, California, Förenta staterna, 94305-5408
- Stanford University Medical Center
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Walnut Creek, California, Förenta staterna, 94598
- Northern California Cancer Specialists Medical Clinic
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Colorado
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Denver, Colorado, Förenta staterna, 80010
- University of Colorado Cancer Center
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Förenta staterna, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Förenta staterna, 96817
- St. Francis Medical Center
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Idaho
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Boise, Idaho, Förenta staterna, 83712
- Mountain States Tumor Institute
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Illinois
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Maywood, Illinois, Förenta staterna, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas - Wichita
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Wichita, Kansas, Förenta staterna, 67214-3882
- CCOP - Wichita
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Förenta staterna, 40536-0093
- Lucille Parker Markey Cancer Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Förenta staterna, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Förenta staterna, 70112-2822
- Louisiana State University School of Medicine
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New Orleans, Louisiana, Förenta staterna, 70115
- Memorial Medical Center
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Shreveport, Louisiana, Förenta staterna, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02118
- Boston Medical Center
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Boston, Massachusetts, Förenta staterna, 02118
- Cancer Research Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Hospital
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Detroit, Michigan, Förenta staterna, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Mississippi
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Jackson, Mississippi, Förenta staterna, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63110-0250
- St. Louis University Health Sciences Center
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Springfield, Missouri, Förenta staterna, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Förenta staterna, 65804
- St. John's Health System
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New York
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New York, New York, Förenta staterna, 10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45236
- Jewish Hospital of Cincinnati, Inc.
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Taussig Cancer Center
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Dayton, Ohio, Förenta staterna, 45409
- Miami Valley Hospital
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Kettering, Ohio, Förenta staterna, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73190
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, Förenta staterna, 97213
- CCOP - Columbia River Program
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Portland, Oregon, Förenta staterna, 97201-3098
- Oregon Cancer Center
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Portland, Oregon, Förenta staterna, 97225
- Providence St. Vincent Medical Center
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Portland, Oregon, Förenta staterna, 97210
- Legacy Cancer Services
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Texas
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Fort Sam Houston, Texas, Förenta staterna, 78234
- Brooke Army Medical Center
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Lackland Air Force Base, Texas, Förenta staterna, 78236-5300
- Wilford Hall - 59th Medical Wing
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Lubbock, Texas, Förenta staterna, 79423
- Texas Tech University Health Science Center
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Lubbock, Texas, Förenta staterna, 79430
- Health Science Center
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San Antonio, Texas, Förenta staterna, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Förenta staterna, 78229
- Methodist Health Care System
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Temple, Texas, Förenta staterna, 76508
- Scott and White Clinic
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Temple, Texas, Förenta staterna, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Förenta staterna, 84112
- Huntsman Cancer Institute
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Salt Lake City, Utah, Förenta staterna, 84143
- LDS Hospital
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Washington
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Seattle, Washington, Förenta staterna, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Förenta staterna, 98104
- Swedish Cancer Institute
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Seattle, Washington, Förenta staterna, 98109-1024
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Förenta staterna, 98195-6043
- University of Washington Medical Center
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Tacoma, Washington, Förenta staterna, 98405-0986
- CCOP - Northwest
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Tacoma, Washington, Förenta staterna, 98401-2197
- Franciscan Health System
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Ontario
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Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS: Cytologically confirmed myelodysplastic syndrome (MDS) Increased blasts (i.e., greater than 1 to 30% peripheral blood blasts and/or 5 to 30% bone marrow blasts) AND International Prognostic Score intermediate 1, intermediate 2, or high risk Refractory anemia with excess blasts OR Refractory anemia with excess blasts in transformation (no presence of auer rods as sole criteria) OR Chronic myelomonocytic leukemia Greater than 1% blasts in the peripheral blood and/or at least 5% blasts in the bone marrow OR MDS related acute myeloid leukemia Arising after documented MDS of at least 60 days Absolute peripheral blast count no greater than 5,000/mm3 Must have genotypically HLA identical sibling donor Must also be enrolled on SWOG-S9910 and SWOG-9007
PATIENT CHARACTERISTICS: Age: 16 to 55 Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: No prior malignancy within past 5 years except: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer in complete remission HIV negative Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No autologous peripheral stem cell transplantation prior to diagnosis of myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia Chemotherapy: No prior chemotherapy for MDS or MDS related acute myeloid leukemia except oral chemotherapy to control leukocytosis or thrombocytosis (e.g., hydroxyurea or etoposide) Endocrine therapy: Not specified Radiotherapy: No radiotherapy prior to diagnosis of MDS or MDS related acute myeloid leukemia Surgery: Not specified
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: behandling
|
dag 0
arm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4
arm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4
both arms per published schedule
GVHD: 15 mg/m2 day 1, 10 mg/m2 day 3, 6 and 11 by IV
both arms: 1200 cGy total dose (6 x 200 fractions)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Event-free survival
Tidsram: every 6 months after stem cell infusion until death or 5 years
|
every 6 months after stem cell infusion until death or 5 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Jeanne E. Anderson, MD, Katmai Oncology Group
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- refraktär anemi med överskott av blaster
- refraktär anemi med överskott av blaster i transformation
- kronisk myelomonocytisk leukemi
- de novo myelodysplastiska syndrom
- sekundära myelodysplastiska syndrom
- sekundär akut myeloid leukemi
- myelodysplastiska syndrom i barndomen
- obehandlad akut myeloid leukemi hos vuxna
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Neoplasmer efter histologisk typ
- Neoplasmer
- Sjukdom
- Benmärgssjukdomar
- Hematologiska sjukdomar
- Precancerösa tillstånd
- Syndrom
- Myelodysplastiska syndrom
- Leukemi
- Leukemi, myeloid
- Leukemi, Myeloid, Akut
- Preleukemi
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Antireumatiska medel
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Dermatologiska medel
- Antifungala medel
- Reproduktionskontrollmedel
- Abortframkallande medel, icke-steroida
- Abortmedel
- Folsyraantagonister
- Calcineurin-hämmare
- Cyklofosfamid
- Metotrexat
- Busulfan
- Cyklosporin
- Cyklosporiner
Andra studie-ID-nummer
- S9920 (Annan identifierare: SWOG)
- U10CA032102 (U.S.S. NIH-anslag/kontrakt)
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