Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio fase 2 aleatorizado, abierto y multicéntrico de Velcade y Fludarabina en comparación con Rituximab y Fludarabina en sujetos con linforma folicular previamente tratados con Rituximab.A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Subjects Previously Treated With Rituximab

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Resumen

2017-03-15 04:06:07
2007-004151-11
26866138-LYM-2033
Estudio fase 2 aleatorizado, abierto y multicéntrico de Velcade y Fludarabina en comparación con Rituximab y Fludarabina en sujetos con linforma folicular previamente tratados con Rituximab.A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Subjects Previously Treated With Rituximab
26866138-LYM-2033

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Janssen-Cilag International NV Belgium

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test VELCADE
Janssen-Cilag International N.V. Velcade
JNJ-26866138 Powder for solution for injection
Intravenous bolus use (Noncurrent)

Detalles del Fármaco (Principio Activo):

JNJ-26866138 bortezomib

Concentración del fármaco:

mg milligram(s) equal

3.5

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Comparator MabThera
Roche Registration Limited Rituximab
Solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

Fludara

Concentración del fármaco:

mg/ml milligram equal

10

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 3:
Test Fludara
Bayer plc Fludara
Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

10

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 4:
Comparator MabThera
Roche Registration Limited Rituximab
Solution for injection
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
No

No
No

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

Linfoma Folicular recidivante o refractario


The primary objective is to determine the complete response rate (CR+CRu) following treatment with VELCADE in combination with fludarabine (VF) compared with rituximab in combination with fludarabine (RF) in subjects with recurrent advanced follicular lymphoma.

The secondary objectives are as follows:? To determine the overall response rate (CR+CRu+PR) ? To determine the duration of response ? To determine time to progression (TTP) ? To determine progression-free survival (PFS)? To determine overall survival (OS)? To determine the time to subsequent anti-lymphoma therapy ? To evaluate the safety and tolerability of VELCADE in combination with fludarabine

No


Potential subjects must satisfy the following criteria to be enrolled in the study:? Male or female subjects 18 years or older? Histologically proven diagnosis of follicular non-Hodgkin?s lymphoma grades 1or 2 according to the World Health Organization classification 41 ? Subjects must have received at least 14 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject?s medical record? Documented relapse or progression following last antineoplastic treatment? At least 1 measurable tumor mass (>=1.5 cm x >=1.0 cm)? Eastern Cooperative Oncology Group [ECOG] performance status =<2 (Attachment 1)? Absolute neutrophil count (ANC) >=1.2 x 109 cells/L? Platelets >=100 x 109 cells/L (subjects should not have received platelet transfusion in the preceding 7 days)? Alanine aminotransferase =<2.5 x upper limit of normal (ULN)? Aspartate aminotransferase =<2.5 x ULN? Total bilirubin =<1.5 x ULN? Measured or calculated creatinine clearance >70 mL/min (see Attachment 2 for the Cockcroft-Gault formula ) ? To participate in the pharmacogenomic component of this study, subjects (or their legally acceptable representative) must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit)? Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum beta-hCG pregnancy test at screening? Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Potential subjects who meet any of the following criteria will be excluded from participating in the study:? Subjects with histological or clinical transformation to an aggressive lymphoma? History of disallowed therapies:? prior treatment with VELCADE or fludarabine.? antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization? nitrosoureas within 6 weeks before randomization? radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization? major surgery within 3 weeks before randomization? chronic use of corticosteroids, such as dexamethasone Note: Prednisone =<15 mg per day or its equivalent is allowed? Peripheral neuropathy or neuropathic pain of Grade 2 or worse? Diagnosed or treated for a malignancy other than NHL except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, DCIS of the breast, or other solid tumors curatively treated with no evidence of disease for >5 years? Active systemic infection requiring treatment. Hepatitis carriers are not excluded from this study. However, hepatitis carriers should be carefully monitored during treatment for any signs of active hepatitis infection and treatment promptly stopped if active hepatitis disease is observed.? Active central nervous system lymphoma. Brain MRI is required only if clinically indicated? Recently received (within the past 6 months) a live virus vaccine? History of allergic reaction attributable to compounds containing boron, mannitol, rituximab, or similar agents? Serious medical conditions (such as severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections, etc) or psychiatric illness likely to interfere with participation in this clinical study? Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is not excluded.

The primary efficacy endpoint is the complete response rate, which is defined as the proportion of responsee valuable subjects (see Section 11.1 for definition of study populations) who achieve a confirmed CR or CRu. Disease response and progression will be evaluated according to modified IWRC criteria by radiographic imaging and other procedures as necessary. The CT scans and other radiographic evaluations will be centrally assessed by an IRC to confirm disease response for the purpose of the efficacy analyses. Additionally, the CT scans or other radiographic evaluations will be locally assessed by a radiologist during the conduct of the study for the purpose of treatment decision-making.

Fase II
  DISEÑO DEL ENSAYO:

No
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

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

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

Si

Centros participantes:


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

1
11
  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:


6

Para estudios internacionales:


25
120

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha