- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 2M9
- Princess Margaret Hospital
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Arizona
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Phoenix, Arizona, Estados Unidos, 85062-2989
- Good Samaritan Medical Center
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Tucson, Arizona, Estados Unidos, 85724
- Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences
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California
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Berkeley, California, Estados Unidos, 94704
- Alta Bates Comprehensive Cancer Center
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Duarte, California, Estados Unidos, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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La Jolla, California, Estados Unidos, 92037
- Scripps Clinic
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Los Angeles, California, Estados Unidos, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Estados Unidos, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Orange, California, Estados Unidos, 92868
- Chao Family Comprehensive Cancer Center
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Orange, California, Estados Unidos, 92613-5600
- St. Joseph Hospital - Orange
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Sacramento, California, Estados Unidos, 95816
- Sutter Cancer center
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Sacramento, California, Estados Unidos, 95817
- University of California Davis Cancer Center
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Stanford, California, Estados Unidos, 94305-5408
- Stanford University Medical Center
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Walnut Creek, California, Estados Unidos, 94598
- Northern California Cancer Specialists Medical Clinic
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Colorado
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Denver, Colorado, Estados Unidos, 80010
- University of Colorado Cancer Center
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Estados Unidos, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Estados Unidos, 96817
- St. Francis Medical Center
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Idaho
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Boise, Idaho, Estados Unidos, 83712
- Mountain States Tumor Institute
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Illinois
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Estados Unidos, 67214
- Cancer Center of Kansas - Wichita
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Wichita, Kansas, Estados Unidos, 67214-3882
- CCOP - Wichita
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0093
- Lucille Parker Markey Cancer Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Estados Unidos, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Estados Unidos, 70112-2822
- Louisiana State University School of Medicine
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New Orleans, Louisiana, Estados Unidos, 70115
- Memorial Medical Center
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Shreveport, Louisiana, Estados Unidos, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center
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Boston, Massachusetts, Estados Unidos, 02118
- Cancer Research Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Detroit, Michigan, Estados Unidos, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110-0250
- St. Louis University Health Sciences Center
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Springfield, Missouri, Estados Unidos, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Estados Unidos, 65804
- St. John's Health System
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New York
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45236
- Jewish Hospital of Cincinnati, Inc.
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Dayton, Ohio, Estados Unidos, 45409
- Miami Valley Hospital
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Kettering, Ohio, Estados Unidos, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73190
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, Estados Unidos, 97213
- CCOP - Columbia River Program
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Portland, Oregon, Estados Unidos, 97201-3098
- Oregon Cancer Center
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Portland, Oregon, Estados Unidos, 97225
- Providence St. Vincent Medical Center
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Portland, Oregon, Estados Unidos, 97210
- Legacy Cancer Services
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Texas
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Fort Sam Houston, Texas, Estados Unidos, 78234
- Brooke Army Medical Center
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Lackland Air Force Base, Texas, Estados Unidos, 78236-5300
- Wilford Hall - 59th Medical Wing
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Lubbock, Texas, Estados Unidos, 79423
- Texas Tech University Health Science Center
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Lubbock, Texas, Estados Unidos, 79430
- Health Science Center
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San Antonio, Texas, Estados Unidos, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Estados Unidos, 78229
- Methodist Health Care System
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Temple, Texas, Estados Unidos, 76508
- Scott and White Clinic
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Temple, Texas, Estados Unidos, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute
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Salt Lake City, Utah, Estados Unidos, 84143
- LDS Hospital
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Washington
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Seattle, Washington, Estados Unidos, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Estados Unidos, 98104
- Swedish Cancer Institute
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Seattle, Washington, Estados Unidos, 98109-1024
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Estados Unidos, 98195-6043
- University of Washington Medical Center
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Tacoma, Washington, Estados Unidos, 98405-0986
- CCOP - Northwest
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Tacoma, Washington, Estados Unidos, 98401-2197
- Franciscan Health System
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: tratamiento
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día 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)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Event-free survival
Periodo de tiempo: every 6 months after stem cell infusion until death or 5 years
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every 6 months after stem cell infusion until death or 5 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Jeanne E. Anderson, MD, Katmai Oncology Group
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- anemia refractaria con exceso de blastos
- anemia refractaria con exceso de blastos en transformación
- leucemia mielomonocítica crónica
- síndromes mielodisplásicos de novo
- síndromes mielodisplásicos secundarios
- leucemia mieloide aguda secundaria
- síndromes mielodisplásicos infantiles
- leucemia mieloide aguda en adultos no tratada
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias por tipo histológico
- Neoplasias
- Enfermedad
- Enfermedades de la médula ósea
- Enfermedades hematológicas
- Condiciones precancerosas
- Síndrome
- Síndromes mielodisplásicos
- Leucemia
- Leucemia Mieloide
- Leucemia Mieloide Aguda
- Preleucemia
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes antirreumáticos
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes dermatológicos
- Agentes antifúngicos
- Agentes de control reproductivo
- Agentes abortivos, no esteroideos
- Agentes abortivos
- Antagonistas del ácido fólico
- Inhibidores de calcineurina
- Ciclofosfamida
- Metotrexato
- Busulfán
- Ciclosporina
- Ciclosporinas
Otros números de identificación del estudio
- S9920 (Otro identificador: SWOG)
- U10CA032102 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre trasplante alogénico de médula ósea
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University Hospital, Basel, SwitzerlandTerminadoBiopsia de Médula ÓseaSuiza