Hemotrial Un proyecto de SEHH

Ensayo clínico

Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FC-R) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone in patients with previously untreated chronic lymphocytic leukaemia

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Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FC-R) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone in patients with previously untreated chronic lymphocytic leukaemia


Resumen

2017-03-15 03:56:02
2004-002787-15
ML17102
Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FC-R) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone in patients with previously untreated chronic lymphocytic leukaemia
CLL-8
ML17102

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
F. Hoffmann-La Roche Ltd Switzerland

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test MabThera
Roche Registration Limited MabThera
Ro 45-2294 Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

100

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Test MabThera
Roche Registration Limited MabThera
Ro 45-2294 Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

500

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Linfomas y otros Síndromes Linfoproliferativos

With an annual incidence of 3/100,000 chronic lymphocytic leukaemia is the most common leukaemia in western countries. Pathogenetically and cytomorphologically CLL belongs to the group of low-grade non-Hodgkin's lymphomas. More than 90 % of the cases are


The objective of this study is to determine the value of immunochemotherapy with FCR in comparison with chemotherapy with FC alone in the first-line therapy of B-CLL. The study is to answer the following questions: • Is combined immunochemotherapy with FCR superior in terms of progression free survival to chemotherapy with FC alone in the first-line therapy of B-CLL? • Is combined immunochemotherapy with FCR a safe alternative to FC chemotherapy alone with regards to the adverse effects?

- Event-free survival - Overall survival - Disease-free survival- Duration of remission- Time to new CLL treatment or death- Rates of molecular, complete and partial remission- Response rates and survival times in biological subgroups- Rates of treatment-related adverse effects- Pharmacoeconomic impact- Quality of life

Information no disponible en EudraCT


• B-CLL confirmed according to NCI Working Group criteria [1] • Binet stage C as well as Binet stage B requiring treatmentAll patients must fulfill the criteria of disease requiring treatment. Disease requiring treatment is defined as:• Binet stage C• Binet stage B plus at least one of the following signs or symptoms:- B symptoms (night sweats, weight loss ? 10% within the previous 6 months, fevers > 38°C or 100.4°F for ? 2 weeks without evidence of infection) or constitutional symptoms (fatigue)- Continuous progression (doubling of peripheral lymphocyte count < 6 months AND absolute lymphocyte count > 50 G/l)- evidence of progressive marrow failure as manifested by the development / worsening of anemia and/or thrombocytopenia- massive, progressive or painful splenomegaly or hypersplenism- massive lymph nodes or lymph node clusters (> 10 cm in longest diameter), danger of organ complications through large lymphomas (e.g. vascular compression, e.g. tracheal narrowing) or progressive lymphadenopathy- Occurrence of symptomatic hyperviscosity problems at leucocyte counts > 200 G/l (symptomatic leucostasis)• No previous treatment of the CLL by chemotherapy, radiotherapy or immunotherapy.• Alkaline phosphatase and transaminases ? 2 x ULN • A negative serum pregnancy test one week prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause.• Willingness to use contraception for the entire duration of the treatment and 2 months thereafter• Patient's written informed consent• Age ? 18 years• Life expectancy > 6 months• ECOG performance status 0-1• Patient's written informed consent

• Stage Binet A• Clinically significant auto-immune cytopenia, Coombs-positive haemolytic anaemia as judged by the treating physician.• Active second malignancy currently requiring treatment (except basal cell carcinoma or tumour treated curatively by surgery)• Pregnancy,and/or nursing• Concomitant disease requiring prolonged use of glucocorticoids (> 1 month)• Known hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the study drugs• CIRS score > 6• Cerebral dysfunction which makes it impossible to perform chemotherapy• Transformation to aggressive B-cell malignancy (eg diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukaemia) .• Active bacterial, viral or fungal infection• Total bilirubin > 2 x ULN• Creatinine clearance < 70 ml/min calculated according to the formula of Cockcroft and Gault• Any coexisting medical or psychological condition that would preclude participation in the required study procedures.

Progression-free survival (PFS)

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Si

Centros participantes:


Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

5
2
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:


0
1

1

Sexo:


1
1

Número planeado de pacientes a incluir:


20

Para estudios internacionales:



760

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado