- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00027560
Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer
Phase II Trial Of Non-Myeloablative Regimen Combining Melphalan, Fludarabine, And Anti-CD52 Monoclonal Antibody (CAMPATH-1H) Followed By An Unmodified Hematopoietic Cell Transplant From An HLA Compatible Related Or Unrelated Donor For Treatment Of Lymphohematopoietic Malignancies
RATIONALE: Giving low doses of chemotherapy, such as melphalan and fludarabine, and a monoclonal antibody, such as alemtuzumab, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well fludarabine, melphalan, alemtuzumab, and peripheral stem cell transplant work in treating patients with hematologic cancer.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
Overall survival-12 months
Overall survival-24 months
Acute Graft-versus-Host Disease Matched Related patients-up to 4 months post transplant
Acute Graft-versus-Host Disease Unrelated and Mismatched related patients- up to 4 months post transplant
Chronic Graft-versus-Host Disease Matched Related patients- up to 2 years post transplant
Chronic Graft-versus-host disease Unrelated and Mismatched related patients- up to 2 years post transplant
- OUTLINE: Patients are stratified according to donor type (HLA-matched related vs HLA-matched unrelated, single HLA-allele disparate related, or unmatched) (HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 1/11/06).
Patients receive a nonmyeloablative regimen comprising alemtuzumab IV over 8 hours on days -8 to -5, fludarabine IV over 30 minutes on days -8 to -4, and melphalan IV over 30 minutes on days -3 and -2. Allogeneic peripheral blood stem cells or bone marrow is infused on day 0.
Patients receive graft-versus host disease prophylaxis comprising cyclosporine IV every 12 hours beginning on day -1 and continuing orally as tolerated until day 100.
Patients are followed every 6 weeks for 6 months, every 3 months for 6 months, every 3-6 months for 1 year, and then annually thereafter or as clinically indicated.
PROJECTED ACCRUAL: A maximum of 50 patients (25 HLA-matched related and 25 HLA-mismatched related or matched unrelated) will be accrued for this study within 2 years (HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 1/11/06).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering 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:
- Disease criteria: This trial is primarily designed for: 1) patients with relapsed or primary refractory non-Hodgkin's lymphoma, 2) chemosensitive relapsed or refractory acute and chronic lymphocytic leukemias, 3) relapsed or primary refractory Hodgkin's Disease, or advanced (Durie-Salmon stage II or III) multiple myeloma, advanced Waldenstrom macroglobulinemia, who, by virtue of advanced age, intensity of prior radiation and/or chemotherapy, history of prior toxicity associated with chemo/radiotherapy or existing organ dysfunction, would be at undue risk of regimen associated mortality if transplanted according to protocols involving myeloablative conditioning regimens.
- Patients with aggressive NHL histologies must have chemo/radiosensitive disease, or have non-progressive disease, or have stable disease on therapy, and be ineligible for an autologous HSC transplant because of disease in the marrow.
- Patients with chronic myeloid leukemia and high risk forms of acute myelogenous leukemia or myelodysplastic syndromes are also eligible in the absence of an alternative active higher priority allogeneic transplant protocol for which they are eligible.
- Age criteria: Patients may be up to 70 years of age. There is no lower age threshold. Patients above the age of 70 may also participate, after evaluation and approval by the BMT Service attendings.
- Absence of active or uncontrolled bacterial, viral, or fungal infection that would contraindicate the use of myelosuppressive chemotherapy.
- Patients must have a healthy HLA-compatible donor, either a matched or single HLA allele disparate related donor or a similarly compatible unrelated donor recruited through the National Marrow Donor Program. Related donors must be willing to participate as research subjects and be willing to receive G-CSF to mobilize PBPC and undergo leukapheresis to donate PBSC. Unrelated donors identified by the NMDP may elect to donate either PBSC after treatment with G-CSF, or bone marrow. These unrelated donors will provide informed consent and their PBSC or bone marrow donations will be obtained at a qualified donor center participating in the NMDP.
- Each patient must be willing to participate as a research subject and must sign an informed consent form after discussion of the nature and risks of the study prior to entering the protocol. Parents or legal guardians of patients who are minors will sign the consent form for these patients after discussion of the nature and risks of the study.
EXCLUSION CRITERIA:
- Female patients who are pregnant or lactating.
- Active or uncontrolled viral (including HIV-1), bacterial or fungal infection.
- Severe renal insufficiency (creatinine >2.0 or creatinine clearance < 30mL/minute)
- Severe hepatic dysfunction, as defined by: total bilirubin greater than 2.5 mg/dL and AST and ALT >3xnl, unless the liver is involved with disease.
- Severe cardiac insufficiency, defined as a resting left ventricular ejection of less than 30% as measured by echocardiography or radionuclide cardiac angiography. Patients on cardiac medications for congestive heart failure are eligible, as long as their LVEF is greater than 30% on medication.
- Severe pulmonary insufficiency, as defined by an adjusted diffusing capacity of less than 40% of predicted value.
- Karnofsky or Lansky score <40%
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
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Consenting individuals will receive pretransplant immunosuppressive cytoreduction, which will consist of 4 days of Campath-1H, 5 days of fludarabine, and two days of melphalan. All therapy should be completed approximately 24-36 hours before administration of the primary allograft. Campath-1H (20mg/dose/day) will be administered for each of four days from day -8 to day -5, inclusive. Each dose will be infused intravenously over 8 hours.
Otros nombres:
Patients will be treated with Cyclosporine as prophylaxis against GvHD.
Cyclosporine will be initiated at least 1 day prior to transplant at a dose of 1.5 mg / kg IV q12h (3 mg / kg / day = total daily dose).
Dose will thereafter be adjusted to maintain a trough serum level of 200-300 ng /ml.
Cyclosporine will be administered intravenously until the patient tolerates full alimentation, at which time conversion to oral dosing to sustain therapeutic levels will be initiated according to standard BMT service guidelines.
Fludarabine, 25mg/m2/d will be administered for each of five days from day -8 to day -4, inclusive.
Each dose will be infused intravenously over 30 minutes.
Melphalan will be administered intravenously over 30 minutes on each of two days from day -3 to day -2, inclusive.
The dose for recipients of HLA-matched related grafts will be 50 mg/m2/day x 2. The dose for recipients of HLA-matched unrelated and HLA-single allele disparate related or unrelated marrow or PBSC transplants will be 70 mg/m2/day x 2.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overall Survival
Periodo de tiempo: 12 months post transplant
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12 months post transplant
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Overall Survival
Periodo de tiempo: 24 months post transplant
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24 months post transplant
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Acute Graft-versus-Host Disease Matched Related Patients
Periodo de tiempo: up to 4 months post transplant
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Grade III-IV Acute Graft-versus-Host Disease
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up to 4 months post transplant
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients
Periodo de tiempo: up to 4 months post transplant
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Grade III-IV Acute Graft-versus-Host Disease
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up to 4 months post transplant
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Extensive Chronic Graft-versus-Host Disease Matched Related Patients
Periodo de tiempo: up to 2 years post transplant
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up to 2 years post transplant
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Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients
Periodo de tiempo: up to 2 years post transplant
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up to 2 years post transplant
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Hugo R. Castro-Malaspina, MD, Memorial Sloan Kettering Cancer Center
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
- linfoma folicular grado 3 recurrente
- Linfoma difuso de células grandes en adultos recidivante
- Linfoma inmunoblástico de células grandes en adultos recidivante
- Linfoma de Burkitt en adultos recidivante
- Linfoma de células pequeñas no hendidas infantil recidivante
- linfoma de células grandes infantil recurrente
- síndromes mielodisplásicos previamente tratados
- leucemia mieloide aguda en adultos con anomalías 11q23 (MLL)
- leucemia mieloide cronica infantil
- síndromes mielodisplásicos infantiles
- leucemia mieloide aguda recurrente en adultos
- linfoma de Hodgkin adulto recurrente
- Linfoma de Hodgkin infantil recurrente/refractario
- Linfoma difuso de células pequeñas hendidas en adultos recidivante
- Linfoma difuso de células mixtas en adultos recidivante
- leucemia mielógena crónica recidivante
- mieloma múltiple en estadio II
- mieloma múltiple en estadio III
- linfoma folicular grado 1 recurrente
- linfoma folicular grado 2 recurrente
- linfoma de la zona marginal recurrente
- linfoma de linfocitos pequeños recurrente
- Linfoma extraganglionar de células B de la zona marginal de tejido linfoide asociado a mucosas
- linfoma de células B de la zona marginal ganglionar
- linfoma esplénico de la zona marginal
- linfoma linfoblástico adulto recurrente
- linfoma de células del manto recurrente
- leucemia linfocítica crónica refractaria
- mieloma múltiple refractario
- leucemia linfoblástica aguda recurrente en adultos
- Macroglobulinemia de Waldenström
- leucemia linfoblástica aguda infantil recurrente
- leucemia mieloide aguda infantil recurrente
- neoplasia mielodisplásica/mieloproliferativa, inclasificable
- linfoma linfoblástico infantil recurrente
- leucemia mieloide crónica atípica, BCR-ABL1 negativo
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Enfermedad
- Enfermedades de la médula ósea
- Enfermedades hematológicas
- Trastornos hemorrágicos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Condiciones precancerosas
- Neoplasias
- Linfoma
- Síndrome
- Síndromes mielodisplásicos
- Mieloma múltiple
- Neoplasias De Células Plasmáticas
- Leucemia
- Preleucemia
- Plasmacitoma
- Trastornos mieloproliferativos
- Enfermedades mielodisplásicas-mieloproliferativas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Inhibidores de enzimas
- Agentes antirreumáticos
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos inmunológicos
- Agentes dermatológicos
- Agentes antifúngicos
- Inhibidores de calcineurina
- Melfalán
- Fludarabina
- Fosfato de fludarabina
- Ciclosporina
- Ciclosporinas
- Alemtuzumab
Otros números de identificación del estudio
- 01-092
- MSKCC-01092
- NCI-G01-2028
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. .
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