Hemotrial Un proyecto de SEHH

Ensayo clínico

First line treatment with rituximab plus fludarabine, cyclophosphamide, mitoxantrone (R-FCM) and maintenance therapy with rituximab in patients diagnosed with chronic lymphocytic leukemia. Tratamiento de primera línea con rituximab combinado con fluradabina, ciclofosfamida y Mitoxantrone (R-FCM) y mantenimiento con rituximab de pacientes con leucemia linfática crónica (LLC)

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Resumen

2017-03-15 03:57:10
2005-001569-33
LLC-R-FCM-1
First line treatment with rituximab plus fludarabine, cyclophosphamide, mitoxantrone (R-FCM) and maintenance therapy with rituximab in patients diagnosed with chronic lymphocytic leukemia. Tratamiento de primera línea con rituximab combinado con fluradabina, ciclofosfamida y Mitoxantrone (R-FCM) y mantenimiento con rituximab de pacientes con leucemia linfática crónica (LLC)
R-FCM in CLL
LLC-R-FCM-1

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Dept. Hematology, Hospital Clinic Spain

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test MabThera®
RocheRegistration Limited, 40. Broadwater Road, We MabTheta
Ro 45-2294 Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:
mg/ml milligram equal

10

Contenido del fármaco

No
Si

No
Information no disponible en EudraCT

No
Si

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

Patients diagnosed with chronic lymphocytic leukemia (CLL) according to the WHO guidelines, within 18 and 71 years and not previously treated

To asess feasibility and toxicity of the quemotherapeutic regimen rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) plus maintenance treatment with rituximab.

1. Response rate of the R-FCM2. Relationship between biological markers and response3. Response duration and progression free survival4. Pharmacokynetic parameters

Information no disponible en EudraCT


1. Age > 17 and < 71 years2. ECOG ? 33. Patients diagnosed with CLL according to the standard criteria4. Active disease defined with the presence of one of the following: - weight loss > 10% within the previous 6 months - Extreme fatigue - Fever > 38oC for > 2 weeks without evidence of infection - Night sweets without evidence of infection - Progressive bone marrow failure as manifested by the development of anemia and/or thrombocytopenia - massive or progressive splenomegaly - massive or progressive lymphadenopathy - progressive lymphocytosis with an increase of > 50% over a 2-month period, or anticipated doubling time of less than 6 months - Patients not previously treated - Informed consent signed

- Age < 18 and > 70 years - previously treated patients - Transformed CLL to a more hystological agressive forms - patients with severe cardiac, pulmonar, neurological, psychiatric or metabolical conditions. - patients receiving high dose of corticosteroid therapies - abnormal hepatic (bilirrubin, ASAT, ALAT, GGT > 2 times the normal values) not related to the CLL - abnormal renal function (creatinin > 1.5 times the normal value or clearance of creatinine < 50 mL/min - Patients diagnosed with other neoplastic conditions (except for localized cutaneous carcinoma) - autoimmune anemia or thrombocytopenia or positive Coombs's test - severe and active infection - pregnancy or breast feeding period - HIV positivity or other sever immunosupressive diseases - Positive HBsAg, HBcAb, or CHV - Participation in another clinical trial

1. To asess feasibility and toxicity of the quemotherapeutic regimen rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) plus treatment maintenance with rituximab. 2. Response rate of the R-FCM3. Relationship between biological markers and response4. Response duration and progression free survival5. Pharmacokynetic parameters

Fase II
  DISEÑO DEL ENSAYO:

No
No

No
No

No
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

No
No

Si

Centros participantes:

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

5
6
  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:

60

Para estudios internacionales:

0
60

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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