Hemotrial Un proyecto de SEHH

Ensayo clínico

A Randomized, Open-Label, Multicenter Study of VELCADE with Rituximab or Rituximab Alone in Subjects with Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non Hodgkin's Lymphoma

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Resumen

2017-03-15 03:58:50
2005-005777-30
26866138-LYM-3001
A Randomized, Open-Label, Multicenter Study of VELCADE with Rituximab or Rituximab Alone in Subjects with Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non Hodgkin's Lymphoma
VELCADE with Rituximab vs. Rituximab alone in NHL
26866138-LYM-3001

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

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Comparator Mabthera 100 mg
Roche - United Kingdom MabThera | rituximab 100 mg (10 mg/mL)
PS-341, 2686613 Solution for infusion
Intravenous drip use (Noncurrent)

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

Si
  FÁRMACO 2:
Comparator MabThera 500 mg
Roche - United Kingdom MabThera | rituximab 500 mg (10 mg/ml)
Solution for infusion
Intravenous drip use (Noncurrent)

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

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

Si
  FÁRMACO 3:
Test VELCADE
JANSSEN-CILAG VELCADE 3.5 mg powder for solution for injection
Powder for solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

26866138 Boronic Acid: [

Concentración del fármaco:

mg/ml milligram equal

10

Concentración del fármaco:

mg milligram(s) equal

3.5

Contenido del fármaco


Si
No

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

Subjects with Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non Hodgkin's Lymphoma


The primary objective of this study is to determine whether VELCADE with rituximab provides benefit to subjects with relapsed or refractory, rituximab naive or sensitive follicular B-NHL relative to treatment with rituximab alone, as assessed by prolongation of PFS

Secondary objectives are to determine the:-ORR (CR + CR unconfirmed [CRu] + PR) to VELCADE in combination with rituximab according to modified criteria developed by the International Workshop to Standardize Response Criteria for NHL (IWRC)-Overall CR rate (CR + CRu)-Duration of response-TTP -Overall survival (OS) rate-One-year survival rate. The safety objective is to evaluate the safety and tolerability of VELCADE in combination with rituximabExploratory objectives are mentioned in the protocol.

Information no disponible en EudraCT


1. Man or woman and age 18 years or older2. Diagnosis of follicular B-NHL of the following subtypes (WHO classification 1997): FL (Grades 1 and 2). 3. Documented relapse or progression following prior antineoplastic treatment. New lesions or objective evidence of progression of existing lesions must document relapse or progression following the previous therapy. If any prior regimen included rituximab, the subject must have responded (CR, CRu, PR), and the TTP from the first dose of rituximab must have been 6 months or more. 4. At least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension and greater than 1.0 cm in the short axis) that has not been previously irradiated, or has grown since previous irradiation5. No active central nervous system lymphoma6. Eastern Cooperative Oncology Group status equal or smaller than 27.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. 8. In countries where health authorities have approved the pharmacogenomic testing, subjects or their legally acceptable representatives must have signed a separate informed consent that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for testing described in Section 9.5, but optional for serum protein testing and future testing.

1. Diagnosed or treated for a malignancy other than NHL within 1 year of randomization, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded.2. Clinical evidence of a transformation from indolent NHL to a more aggressive form of NHL.3. History of disallowed therapies: 4. Prior treatment with VELCADE5. Antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization6. Nitrosoureas within 6 weeks before randomization7. Radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization8. Stem cell transplant within 6 months before randomization9. Major surgery within 2 weeks before randomization10. Residual toxic effects of previous therapy or surgery of Grade 3 or worse11. Peripheral neuropathy or neuropathic pain of Grade 2 or worse12. Have received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.13. History of allergic reaction attributable to compounds containing boron or mannitol14. Known anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab including polysorbate 80 and sodium citrate dihydrate15. Concurrent treatment with another investigational agent 16. Female subject who is pregnant or breast-feeding

The primary endpoint is Progression Free survival is defined as the interval between the date of randomization and the date of PD or death, whichever is first reported in the intent-to-treat (ITT) population. Subjects who withdraw from the study (i.e., withdrawal of consent, lost to follow-up) or change therapy without documented progression will be censored at the time of the last adequate disease assessment. Subjects who complete the study, have not progressed, and are still alive at the cut-off date of the final analysis will be censored at the last adequate disease assessment.Secondary Endpoints: please refer to the protocol.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:


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

3
4
  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:


16

Para estudios internacionales:


275
670

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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En Marcha