Hemotrial Un proyecto de SEHH

Ensayo clínico

A PHASE II, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED STUDY OF THE SAFETY,PHARMACOKINETICS, AND EFFICACY OF MULTIPLE DOSES OF APOMAB ADMINISTERED INTRAVENOUSLY IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH FOLLICULAR, CD20-POSITIVE B-CELL NON-HODGKIN’S LYMPHOMA THAT HAS PROGRESSED FOLLOWING PREVIOUS RITUXIMAB THERAPYESTUDIO FASE II, ALEATORIZADO , DOBLE CIEGO, CONTROLADO CON PLACEBO PARA VALORAR LA SEGURIDAD, FARMACOCINÉTICA Y EFICACIA DE MULTIPLES DOSIS DE APOMAB ADMINISTRADAS POR VIA INTRAVENOSA EN COMBINACIÓN CON RITUXIMAB EN PACIENTES CON LINFOMA NON HODGKING FOLICULAR CON CELULAS B CD20 POSITIVAS QUE HAN PROGRESADO DESPUÉS DE UNA TERAPIA PREVIA CON RITUXIMAB

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Resumen

2017-03-15 04:04:40
2007-001666-32
APM4083g
A PHASE II, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED STUDY OF THE SAFETY,PHARMACOKINETICS, AND EFFICACY OF MULTIPLE DOSES OF APOMAB ADMINISTERED INTRAVENOUSLY IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH FOLLICULAR, CD20-POSITIVE B-CELL NON-HODGKIN’S LYMPHOMA THAT HAS PROGRESSED FOLLOWING PREVIOUS RITUXIMAB THERAPYESTUDIO FASE II, ALEATORIZADO , DOBLE CIEGO, CONTROLADO CON PLACEBO PARA VALORAR LA SEGURIDAD, FARMACOCINÉTICA Y EFICACIA DE MULTIPLES DOSIS DE APOMAB ADMINISTRADAS POR VIA INTRAVENOSA EN COMBINACIÓN CON RITUXIMAB EN PACIENTES CON LINFOMA NON HODGKING FOLICULAR CON CELULAS B CD20 POSITIVAS QUE HAN PROGRESADO DESPUÉS DE UNA TERAPIA PREVIA CON RITUXIMAB
APM4083g

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Genentech Inc United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test MabThera
F.Hoffman La-Roche Apomab
Intravenous infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

PRO95780 Apomab

Concentración del fármaco:

mg/kg milligram up to

15

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

Si
  FÁRMACO 2:
Comparator
Mabthera
Intravenous infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Rituximab

Concentración del fármaco:

mg/m2 milligram equal

375

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

Si
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Intravenous infusion

Intravenous use

Información General



Linfomas y otros Síndromes Linfoproliferativos

Follicular, CD20-Positive B-Cell Non-Hodgkin's LymphomaLinfoma Non-Hodgking folicular con céluas B CD20 positivas


To evaluate the safety and tolerability of Apomab when combined with rituximab for the treatment of patients with relapsed follicular, CD20-positive B-cell non-Hodgkin’slymphoma (NHL). To make a preliminary assessment of the efficacy of Apomab when combined with rituximab for the treatment of patients with relapsed follicular, CD20-positive B-cell NHL, as measured byobjective response rate.

To make a preliminary assessment of the efficacy of Apomab when combined with rituximab for the treatment of patients with relapsed follicular, CD20-positive B-cell NHL, as measured by progression-free survival, duration of response, and overall survival. To evaluate the serum pharmacokinetics of Apomab and rituximab when combined for the treatment of patients with relapsed follicular, CD20-positive B-cell NHL.

No


>Signed Informed Consent Form> Age ?18 years>Diagnosis of follicular, CD20-positive B-cell NHL classified as Grade 1, 2, or3a according to the WHO classification of malignant lymphomas>Progression of disease after an objective response (CR/CRu or PR) or SDlasting 6 months following completion of the most recent rituximab-containing regimen>A rituximab-containing regimen is defined as rituximab as a single agentduring induction and/or maintenance, or in combination with other agents.>Measurable disease (according to modified IWG Criteria; see Appendix B)ECOG performance status of 0 or 1 (see Appendix D)>Life expectancy of 3 months>Willingness and capability to be accessible for follow-up until studytermination or death>For patients of reproductive potential (both males and females), use of areliable means of contraception (e.g., contraceptive pill, intrauterine device[IUD], barrier methods) throughout the trial and for 1 year following their lastexposure to study treatment

>Grade 3b follicular lymphoma (according to the WHO classification) orhistologic transformation from follicular lymphoma to aggressive lymphoma>Prior radiotherapy to a lesion(s) that will be used to assess response unlessthat lesion(s) shows clear evidence of lymphoma progression at baseline(i.e., ?50% increase in the product of the longest perpendicular diameters ofthe lesion [greatest transverse diameter perpendicular diameter] whencompared with the nadir of lesion dimensions following radiotherapy and1.5 cm in the greatest transverse diameter)>Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1 orradiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior toCycle 1, Day 1>Prior radio-immunotherapy, including radiolabeled antibodies>Concurrent systemic corticosteroid therapy (except low-dose corticosteroidtherapy used to treat an illness other than lymphoma)>Other invasive malignancies within 5 years prior to Cycle 1, Day 1 (other thanbasal or squamous cell carcinoma of the skin or in situ carcinoma of thecervix treated with curative intent)>History or evidence on physical examination of central nervous system(CNS) disease (e.g., primary brain tumor, CNS lymphoma, seizures notcontrolled with standard medical therapy, any brain metastases, or historyof stroke)>Prior treatment with agonistic DR4 or DR5 antibodies or Apo2L/TRAIL>General Medical Concerns>Current or recent (within the 28 days prior to Cycle 1, Day 1) participation inanother experimental drug study>Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,myocardial infarction within 1 year prior to Cycle 1, Day 1, unstable angina),New York Heart Association (NYHA; see Appendix E) Grade II or greatercongestive heart failure, serious cardiac arrhythmia requiring medicationwithin 1 year prior to Cycle1, Day 1, or Grade II or greater peripheral vasculardisease (see Appendix F) at study entry>Active infection requiring parenteral antibiotics on Cycle 1, Day 1Protocol: Apomab—Genentech, >Major surgical procedure (excluding lymph node biopsy) or significanttraumatic injury within 28 days prior to Cycle 1, Day 1, or anticipation of needfor major surgical procedure during the course of the study>Pregnancy (positive pregnancy test) or breast feeding>Serious, non-healing wound, ulcer, or bone fractureLaboratory valuesANC 1500/L (may not be treated with G-CSF to maintain or exceedthis level) Platelet count 75,000/L Total bilirubin1.6 mg/dL AST or ALT 2.5 the upper limit of normal (ULN) Serum creatinine 2.0 mg/dL or measured creatinine clearance?50 mL/min Hemoglobin 9 g/dL (may not be transfused or treated with erythropoietin to maintain or exceed this level)>Known human immunodeficiency virus (HIV) infection, seropositivity forhepatitis B surface antigen (HBsAg), hepatitis B IgG or IgM core antibody,or hepatitis C virus (HCV) antibody>History of other disease, metabolic dysfunction, physical finding,or laboratory finding giving reasonable suspicion of a disease or conditionthat contraindicates use of an investigational drug or that might affectinterpretation of the results of the study or render the patient at high risk fromtreatment complications

Objective response (defined as a PR or CR/CRu, occurring within 8 months post-randomization), as determined by the IRF using modified IWG Criteria

Fase II
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
Si

No
Information no disponible en EudraCT

Si

Centros participantes:


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

3
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:


12

Para estudios internacionales:


25
80

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha