Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio de fase III, aleatorizado y en doble ciego, de galiximab en combinación con rituximab frente a rituximab en combinación con placebo en el tratamiento de sujetos con linfoma no Hodgkin folicular en recidiva o refractario

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Estudio de fase III, aleatorizado y en doble ciego, de galiximab en combinación con rituximab frente a rituximab en combinación con placebo en el tratamiento de sujetos con linfoma no Hodgkin folicular en recidiva o refractario


Resumen

2017-03-15 03:57:47
2005-003836-22
114-NH-301
Estudio de fase III, aleatorizado y en doble ciego, de galiximab en combinación con rituximab frente a rituximab en combinación con placebo en el tratamiento de sujetos con linfoma no Hodgkin folicular en recidiva o refractario
114-NH-301

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Biogen Idec Ltd. United Kingdom

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test MabThera 100mg
Roche Registration Limited United Kingdom Galiximab
I Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Galiximab IDEC 114, anti-

Concentración del fármaco:

mg/ml milligram equal

50

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
Si

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Test MabThera 500mg
Roche Registration Limited United Kingdom
Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

RITUXIMAB

Concentración del fármaco:

mg/ml milligram equal

10

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
Si

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 3:
Test
Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

RITUXIMAB

Concentración del fármaco:

mg/ml milligram equal

10

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
Si

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Solution for infusion

Intravenous use

Información General



Linfomas y otros Síndromes Linfoproliferativos

Relapsed or Refractory, Follicular Non-Hodgkin’s Lymphoma


To compare the clinical benefit of galiximab in combination with rituximab with that of rituximab monotherapy for the treatment of subjects with relapsed or refractory, follicular NHL.

· To further characterize the safety profile of galiximab in combination with rituximab.· To further characterize the pharmacokinetics (PK) of 4 infusions of galiximab in combination with rituximab.

No


To be considered for registration and randomization into this study, subjects must satisfy all of the following criteria:1. Must give written informed consent and any authorizations as required by local law2. Aged ?18 years old at the time of informed consent3. Histologically confirmed follicular NHL Grade 1-3a (if the subject has received any intervening lymphoma therapy since the most recent biopsy, a repeat biopsy will be required to exclude transformation) 4. Relapsed or progressive disease after at least 1 chemotherapy requiring treatment as determined by one of the following:- Documented disease progression by CT scan using the International Workshop Response Criteria (IWRC) as described in protocol Appendix C- The presence of B symptoms- Bulky disease (at least 1 lesion >5 cm)- Laboratory abnormalities (cytopenias)- Presence of masses which are causing ongoing clinical symptoms5. Bidimensionally measurable disease with at least 1 lesion ?2.0 cm in a single dimension6. Hematologic, hepatic, and renal function parameters satisfying the following:- Bilirubin ?2.0 mg/dL- AST (SGOT) ?2 x upper limit of normal (ULN) and ALT (SGPT) ? 2 x ULN- Serum creatinine ? 2.0 mg/dL- Hemoglobin ? 8.0 g/dL- Absolute neutrophil count ? 1500 cells/mm3- Platelet count ? 75,000 plts/mm37. WHO Performance Status ? 28. Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs9. Expected survival of ? 3 months10. Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment.

Unless otherwise specified, candidates will be excluded from study entry if any of thefollowing exclusion criteria exist at the time of randomization:1. Follicular lymphoma Grade 3b2. Previous exposure to galiximab or any anti-CD80 antibody3. Known hypersensitivity to murine proteins4. Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months)5. Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior toStudy Day 1 (6 weeks if nitrosourea or mitomycin-C)6. Prior lymphoma vaccine therapy within 12 months prior to Study Day 17. Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 18. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 monthsprior to Study Day 19. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 110. Prior allogeneic transplant11. Transfusion-dependent subjects12. Known history of hepatitis or hepatic disease. (Although testing for hepatitis B is not mandatory, this should be considered for all subjects considered at high risk for hepatitis B infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B exposure should be excluded unless the serological findings are clearly due to vaccination.)13. Presence of chronic lymphocytic leukemia (CLL), marginal zone lymphoma,mucosa-associated lymphoid tissue (MALT)14. Presence of central nervous system (CNS) lymphoma15. Known history of HIV infection or AIDS16. Prior diagnosis of aggressive NHL or mantle-cell lymphoma17. Histologic transformation18. Presence of pleural or peritoneal effusion with positive cytology for lymphoma19. Another primary malignancy requiring active treatment (except hormonal therapy)20. Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor21. New York Heart Association Class III or IV cardiac disease or myocardial infarctionwithin 6 months prior to Study Day 122. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 123. History of alcoholism or substance abuse within the 2 years prior to Study Day 124. Pregnant or currently breastfeeding

The primary study endpoint is Progression-Free Survival (PFS).

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

Si
No

Si

Centros participantes:


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

4
7
  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:


Para estudios internacionales:


348
700

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha