Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia
Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming
RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.
PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
- Assess the clinical outcomes, survival, and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
- Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.
OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.
Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.
Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.
PROJECTED ACCRUAL: Not specified
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota Cancer Center
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
- Philadelphia chromosome positive OR
- BCR/ABL rearrangement
- Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols
- 70 and under
Performance status:
- Age 65-70 years:
- Karnofsky 80-100%
- Under 65 years:
- Karnofsky 90-100%
Renal:
- Age 65-70 years:
- Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
- Under 65 years:
- Not specified
Cardiovascular:
- Age 65-70 years:
- LVEF at least 45%
Pulmonary:
- Age 65-70 years:
- If history of smoking or respiratory symptoms, spirometry and DLCO must be greater then 50% of predicted
- Normal organ function (excluding bone marrow)
Exclusion Criteria:
- Blast crisis or post blast crisis
- Severe fibrosis defined by bilateral trephine biopsies
- Splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Patients with CML
Patients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML)
|
intravenously over 2 hours on day 1 and on days -7 and -6
Otros nombres:
filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis.
Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover
Otros nombres:
Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression
Otros nombres:
Patients receive the PBSC transplantation on day 0.
Otros nombres:
total body irradiation twice a day on days -4 through -1
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
|---|
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Time to hemopoietic recovery after transplantation
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Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples
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Medidas de resultado secundarias
Medida de resultado |
|---|
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Causa de la muerte
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Time to initial hospital discharge
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Peritransplantation toxicity
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Quality of life at various time points
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Catherine M. Verfaillie, MD, Masonic Cancer Center, University of Minnesota
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Leucemia
- Leucemia Mieloide
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Agentes antirreumáticos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Interferones
- Interferón-alfa
- Ciclofosfamida
Otros números de identificación del estudio
- 1996LS183
- UMN-MT-1996-11 (Otro identificador: Blood and Marrow Transplantation Program)
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