Combination Chemotherapy With or Without Total-Body Irradiation Followed By Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
17 de julio de 2015 actualizado por: City of Hope Medical Center
High-Dose Therapy and Autologous Stem Cell Transplantation During Remission in Poor-Risk Age-Adjusted International Prognostic Index High and High-Intermediate Risk Group Patients With Intermediate Grade and High-Grade Non-Hodgkin's Lymphoma Including Mantle Cell Lymphoma
RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The patient's stem cells are then 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 the side effects of giving combination chemotherapy together with or without total-body irradiation followed by a stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
OBJECTIVES:
- To evaluate the outcome of patients with poor-risk, age-adjusted International Prognostic Index high- and high-intermediate-risk, intermediate- and high-grade non-Hodgkin lymphoma undergoing high-dose therapy comprising etoposide and cyclophosphamide, either carmustine or total-body irradiation, and autologous stem cell transplantation (ASCT) given as a consolidation therapy.
- To evaluate the role of high-dose therapy and ASCT during first partial or complete remission (1PR/CR) in patients with poor-risk primary mediastinal large cell lymphoma.
- To evaluate the role of high-dose therapy and ASCT during first 1PR/CR in patients with advanced-stage mantle cell lymphoma.
- To evaluate the short-term and long-term toxicities of high-dose therapy and ASCT when performed during 1PR/CR in patients with poor-risk aggressive lymphomas.
OUTLINE: Patients are stratified according to disease (diffuse mixed, diffuse large cell, and immunoblastic lymphoma vs primary mediastinal large cell lymphoma vs small noncleaved cell lymphoma vs stage IV mantle cell lymphoma).
Patients' peripheral blood stem cells (PBSC) are collected after mobilization. A minimum of 2.0 x 10^6 CD34+ cells/kg must be collected. Patients experiencing disease progression during stem cell collection will be removed from study. Patients are assigned to undergo 1 of 2 therapeutic regimens.
- Regimen 1: Patients undergo total-body irradiation (TBI) on days -8 to -5 and receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo autologous PBSC transplantation on day 0.
- Regimen 2 (for patients who have received any prior thoracic irradiation or patients who underwent previous irradiation that precludes the use of TBI): Patients receive carmustine IV over 2 hours on days -7 to -5. Patients then receive etoposide and cyclophosphamide and undergo autologous PBSC transplantation as in regimen 1.
Patients with residual bulky disease greater than 5 cm may undergo involved-field radiotherapy before or after transplantation.
Patients are followed at days 7, 14, 21, 100 and 180 after PBSC transplantation, every 6 months for 3 years, and then annually thereafter.
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Good Samaritan Regional Medical Center
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California
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Duarte, California, Estados Unidos, 91010-3000
- City of Hope National Medical Center--Main Campus
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
16 años a 59 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- DISEASE CHARACTERISTICS:
- Biopsy-proven diagnosis of high-grade (small noncleaved cell lymphoma [SNCCL] or immunoblastic lymphoma) or intermediate-grade non-Hodgkin lymphoma (NHL) including mantle cell lymphoma (MCL)
SNCCL patients with all of the following factors at presentation of disease:
- Lactate dehydrogenase (LDH) > 500 IU/L
- Unresectable bulky mass > 10 cm
- Stage IV disease with bone marrow involvement
- MCL Patients with stage IV disease or in International Prognostic Index (IPI) high- or high-intermediate-risk group at the time of diagnosis
- Considered at diagnosis to be high- (3 risk factors) or high-intermediate-risk (2 risk factors) based on an age-adjusted IPI
- Poor prognostic factors at diagnosis include stage III or IV disease, lactate dehydrogenase (LDH) level above normal, or ECOG performance status (PS) 2-4
- Patients with primary mediastinal large cell lymphoma with or without sclerosis who at diagnosis had elevated LDH level with bulky mediastinal mass > 10 cm associated with a pleural effusion on chest radiography or computer tomography, or who have persistent mediastinal mass with positive disease by post-treatment gallium GA 67 scan
- Must have attained a complete response or partial response to first-line standard conventional chemotherapy
- ECOG PS 0-1 OR Karnofsky PS 80-100%
- Serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min
- FEV_1 > 65% of predicted measurement or DLCO ≥ 45% of predicted measurement
- Cardiac ejection fraction > 50% by echocardiogram
- Bilirubin ≤ 1.5 x normal
- SGOT or SGPT ≤ 2 x normal
Exclusion Criteria:
- Evidence of lymphoma or < 10% lymphomatous involvement of bone by bilateral bone marrow aspiration and biopsy
- Abnormal cytogenetic study of bone marrow aspirate sample NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- Positive HIV antibody
- Prior malignancies except for adequately treated basal cell or squamous cell carcinoma of the skin
- Hepatitis B surface antigen positivity
- Prior bone marrow transplantation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior bone marrow transplantation
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Irradiation in conditioning
total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor (G-CSF), autologous hematologic stem cell transplantation, peripheral blood stem cell transplantation
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Used in Both Arms
Otros nombres:
Used in Both Arms
Otros nombres:
Both arms are given autologous stem cell transplantation
Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the material, autologous transplant is the modality).
Unique to the Radiation in Conditioning Arm
G-CSF is given in both treatment arms, both to mobilize stem cells before apheresis, and to promote recovery of granulocytes after stem-cell re-infusion.
Otros nombres:
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Comparador activo: Carmustine in conditioning
Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor (G-CSF), autologous hematopoietic stem cell transplantation, peripheral blood stem cell transplantation
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Used in Both Arms
Otros nombres:
Used in Both Arms
Otros nombres:
Both arms are given autologous stem cell transplantation
Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the material, autologous transplant is the modality).
G-CSF is given in both treatment arms, both to mobilize stem cells before apheresis, and to promote recovery of granulocytes after stem-cell re-infusion.
Otros nombres:
Unique to the Carmustine in Conditioning arm
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Progression
Periodo de tiempo: Assessed at date of progression post-transplant
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Event will be recorded if it occurs any time post-transplant, until date of death, last recorded contact, or end-of-study; whichever comes first. Below is reported Progression-free Survival: event is relapse or progression, or death. |
Assessed at date of progression post-transplant
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Mortality
Periodo de tiempo: Assessed at date of death post-transplant
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Event will be recorded if it occurs any time from the date of transplant until the end-of-study date, or the date of last contact, whichever comes first.
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Assessed at date of death post-transplant
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Short-term and Long-term Treatment-related Toxicities
Periodo de tiempo: Any time after transplant
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Patient may be assessed for toxicities any time after transplant, up to death, last contact date, or end-of-study date.
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Any time after transplant
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 1998
Finalización primaria (Actual)
1 de julio de 2011
Finalización del estudio (Actual)
1 de julio de 2011
Fechas de registro del estudio
Enviado por primera vez
15 de noviembre de 2007
Primero enviado que cumplió con los criterios de control de calidad
15 de noviembre de 2007
Publicado por primera vez (Estimar)
16 de noviembre de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de agosto de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2015
Última verificación
1 de julio de 2015
Más información
Términos relacionados con este estudio
Palabras clave
- Linfoma difuso de células grandes en adultos en estadio III
- Linfoma inmunoblástico de células grandes en adultos en estadio III
- Linfoma de Burkitt en adultos en estadio III
- Linfoma difuso de células grandes en adultos en estadio IV
- Linfoma inmunoblástico de células grandes en adultos en estadio IV
- Linfoma de Burkitt en adultos en estadio IV
- Linfoma difuso de células mixtas en adultos en estadio III
- Linfoma difuso de células mixtas en adultos en estadio IV
- linfoma de células del manto en estadio III
- linfoma de células del manto en estadio IV
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Linfoma
- Linfoma No Hodgkin
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antirreumáticos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Adyuvantes, Inmunológicos
- Ciclofosfamida
- Etopósido
- Lenograstim
- Carmustina
Otros números de identificación del estudio
- 97133
- P30CA033572 (Subvención/contrato del NIH de EE. UU.)
- CHNMC-97133 (Otro identificador: City of Hope)
- CDR0000573523 (Identificador de registro: NCI PDQ)
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