Hemotrial Un proyecto de SEHH

Ensayo clínico

A randomized, double-blind, placebo-controlled Phase 3 study of SGN-35 (brentuximab vedotin) and best supportive care (BSC) versus placebo and BSC in the treatment of patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).Estudio de fase III aleatorizado, doble ciego, controlado con placebo de SGN-35 (brentuximab vedotin) y mejor tratamiento asistencial (BSC) frente a placebo y BSC en el tratamiento de pacientes con alto riesgo de linfoma de Hodgkin (HL) residual tras trasplante autólogo de células madre (ASCT)

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Resumen

2017-03-15 04:13:42
2009-016947-20
SGN35-005
A randomized, double-blind, placebo-controlled Phase 3 study of SGN-35 (brentuximab vedotin) and best supportive care (BSC) versus placebo and BSC in the treatment of patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).Estudio de fase III aleatorizado, doble ciego, controlado con placebo de SGN-35 (brentuximab vedotin) y mejor tratamiento asistencial (BSC) frente a placebo y BSC en el tratamiento de pacientes con alto riesgo de linfoma de Hodgkin (HL) residual tras trasplante autólogo de células madre (ASCT)
SGN35-005

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Seattle Genetics, Inc. United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
brentuximab vedotin
SGN-35
Intravenous use

Detalles del Fármaco (Principio Activo):
SGN-35 cAC10-vcMMAE, c

Concentración del fármaco:
mg/ml milligram equal

5

Contenido del fármaco

Si
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
Powder for concentrate for solution for infusion

Intravenous use

Información General

Terapia Celular, Linfomas y otros Síndromes Linfoproliferativos, Trasplante Hematopoyético

Patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).Pacientes con alto riesgo de linfoma de Hodgkin (HL) residual tras trasplante autólogo de células madre (ASCT)

The primary objective of this study is to compare the progression-free survival (PFS) of SGN-35 and best supportive care (BSC) versus placebo and BSC.

The secondary objectives are:- To compare overall survival (OS) between the 2 treatment arms- To evaluate the safety and tolerability of SGN-35 compared to placebo-To characterize the incidence of anti-therapeutic antibodies (ATA)

No


1. Patients with HL who have received ASCT in the previous 30-45 days.2. Patients at high risk of residual HL post ASCT as indicated by at least one of the following:- History of refractory HL (defined as patients progressing on or failing to achieve a complete remission following frontline standard chemotherapy (6 to 8 cycles) or a combined modality treatment program)- Relapsed or progressive HL that occurs <12 months from the end of frontline standard chemotherapy or a combined modality treatment program- Extranodal involvement at the time of pre-ASCT relapse (including extranodal extension of nodal masses into adjacent vital organs)3. Histologically-confirmed HL.4. Age greater than or equal to 18 years.5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.6. The following required baseline laboratory data: absolute neutrophil count (ANC) >=1000/microL, platelets >=50,000/microL (unsupported), bilirubin =<1.5X upper limit of normal (ULN) or =<3X ULN for patients with Gilbert´s disease, serum creatinine =<1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5X ULN.7. Females of childbearing potential must have a negative serum or urine beta-hCG pregnancy test result within 7 days prior to the first dose of SGN-35. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.8. Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug.9. Patients or their legally authorized representative must provide written informed consent.

1. Previous treatment with SGN-35.2. Previously received an allogeneic transplant.3. Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT.4. History of another primary malignancy that has not been in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, fully excised melanoma in situ [Stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)5. Known cerebral/meningeal disease.6. Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first study dose.7. Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents.8. Women who are pregnant or lactating.9. Patients with a known hypersensitivity to any excipient contained in the drug formulation.10. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.

The primary efficacy endpoint of this study is progression-free survival (PFS) per an independent review facility (IRF).

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
Si

No
No

Si

Centros participantes:

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

6
0
  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:

19

Para estudios internacionales:

192
322

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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