Combination Chemotherapy With or Without Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia
A Randomized Phase II Trial of Fludarabine, Cyclophosphamide and Mitoxantrone (FCM) With or Without Rituximab in Previously Treated Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with rituximab may kill more cancer cells. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase II trial is studying how well giving combination chemotherapy with or without rituximab works in treating patients with previously treated chronic lymphocytic leukemia.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Assess the efficacy and safety of fludarabine, cyclophosphamide, and mitoxantrone hydrochloride with or without rituximab in patients with previously treated chronic lymphocytic leukemia.
- Determine the overall response rate, defined as complete or partial remission, in these patients.
Secondary
- Determine the proportion of patients with undetectable minimal residual disease.
- Determine the 2-year progression-free survival of these patients.
- Determine the 2-year overall survival of these patients.
- Determine the toxicity of this regimen.
OUTLINE: This is a randomized, controlled, open-label, parallel group, multicenter study. Patients are stratified according to prior treatment with fludarabine (refractory vs not refractory or naive). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral fludarabine* and oral cyclophosphamide* on days 1-5 and mitoxantrone hydrochloride IV on day 1.
- Arm II: Patients receive fludarabine*, cyclophosphamide*, and mitoxantrone hydrochloride as in arm I. Patients also receive rituximab IV on day 1.
NOTE: *If the oral regimen is not tolerated, patients may receive fludarabine IV and cyclophosphamide IV on days 1-3.
Treatment in both arms repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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England
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Birmingham, England, Reino Unido, B9 5SS
- Birmingham Heartlands Hospital
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Blackpool, England, Reino Unido, FY3 8NR
- Blackpool Victoria Hospital
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Canterbury, England, Reino Unido, CT2 7NR
- Kent and Canterbury Hospital
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Carshalton, England, Reino Unido, SM5 1AA
- St Helier Hospital
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Dartford Kent, England, Reino Unido, DA2 8DA
- Darent Valley Hospital
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Gillingham Kent, England, Reino Unido, ME7 5NY
- Medway Maritime Hospital
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Leeds, England, Reino Unido, LS1 3EX
- Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
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Leicester, England, Reino Unido, LE1 5WW
- Leicester Royal Infirmary
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Liverpool, England, Reino Unido, L7 8XP
- Royal Liverpool and Broadgreen Hospitals NHS Trust
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Maidstone, England, Reino Unido, ME16 9QQ
- Maidstone Hospital
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Manchester, England, Reino Unido, M20 4BX
- Christie Hospital Nhs Trust
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Truro, Cornwall, England, Reino Unido, TR1 3LJ
- Royal Cornwall Hospital
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Tunbridge Wells, Kent, England, Reino Unido, TN4 8AT
- Kent and Sussex Hospital
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Wishaw, England, Reino Unido, ML2 0DP
- Wishaw General Hospital
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Scotland
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Airdrie, Scotland, Reino Unido, ML6 0JF
- Monklands General Hospital
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Wales
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Cardiff, Wales, Reino Unido, CF14 4XW
- University Hospital of Wales
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia requiring therapy
- Previously treated with ≥ 1 chemotherapeutic regimen
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 12 weeks
- Creatinine clearance ≥ 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use effective contraception for 4 weeks before, during, and for 6 months after completion of study treatment
- Fertile male patients must use effective contraception during and for 6 months after completion of study treatment
- No history of anaphylaxis after exposure to rat or mouse-derived complementary-determining region (CDR)-grafted humanized monoclonal antibodies
- No toxicity attributable to purine analogues (e.g., autoimmune hemolytic anemia, neurological toxicity, or allergy)
- No active infection
- No other severe (particularly cardiac or pulmonary) diseases or mental disorders that would preclude study participation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior fludarabine (or other purine analogues) combined with cyclophosphamide and mitoxantrone hydrochloride
- No prior rituximab, either alone or in combination with chemotherapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Overall response rate as measured by NCI Response Criteria
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Medidas de resultado secundarias
Medida de resultado |
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Toxicidad
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Supervivencia global a los 2 años
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Supervivencia libre de progresión a los 2 años
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Proportion of patients with undetectable minimal residual disease
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Peter Hillmen, MD, Leeds General Infirmary
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Leucemia de células B
- Leucemia
- Leucemia Linfocítica Crónica De Células B
- Leucemia Linfoide
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Agentes antirreumáticos
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Agentes antineoplásicos inmunológicos
- Ciclofosfamida
- Rituximab
- Fludarabina
- Fosfato de fludarabina
- Mitoxantrona
Otros números de identificación del estudio
- CTRU-NCRI-UKCLL01-FCM/FCM-R
- CDR0000485181 (Identificador de registro: PDQ (Physician Data Query))
- EU-20626
- ROCHE-NCRI-UKCLL01-FCM/FCM-R
- ISRCTN77546448
- EUDRACT-2004-003982-34
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