Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio aleatorizado, abierto, multicéntrico, fase 2 de combinación de VELCADE, Rituximab, Ciclofosfamida, Doxorubicina, y Prednisona (VR-CAP) o Rituximab, Ciclofosfamida, Doxorubicina, Vincristina, y Prednisona (R-CHOP) en sujetos con nuevo diagnostico de Linfoma de células B grandes difusas del subtipo de células B no de centro germinal.

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Resumen

2017-03-15 04:11:28
2009-012280-34
26866138-LYM-2034
Estudio aleatorizado, abierto, multicéntrico, fase 2 de combinación de VELCADE, Rituximab, Ciclofosfamida, Doxorubicina, y Prednisona (VR-CAP) o Rituximab, Ciclofosfamida, Doxorubicina, Vincristina, y Prednisona (R-CHOP) en sujetos con nuevo diagnostico de Linfoma de células B grandes difusas del subtipo de células B no de centro germinal.
26866138-LYM-2034

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

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test VELCADE 3,5 mg, polvo para solución inyectable
JANSSEN-CILAG INTERNATIONAL N.V ENDOXAN
L01AA01 Powder for solution for injection
Intravenous bolus use (Noncurrent)

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

Si
  FÁRMACO 2:
Comparator ENDOXAN
Baxter Poland DOXORUBICIN
L01DB01 Powder for solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

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

Si
  FÁRMACO 3:
Comparator Doxorubicin
Pharmachemie B.V. Prednisone
H02AB07 Solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

ENDOXAN

Concentración del fármaco:

g gram(s) equal

1

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 Decortin
Merck GmbH Vincristin
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

RITUXIMAB

Concentración del fármaco:

% (W/V) percent equal

0.2

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 5:
Comparator MABTHERA 100 mg concentrado para solución para per
ROCHE REGISTRATION LIMITED Prednisone
Solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

RITUXIMAB

Concentración del fármaco:

mg milligram(s) equal

5

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 6:
Comparator Vincrisin
Teva Pharma Belgium N.V.
Solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

100

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 7:
Comparator Decortin
Merck GmbH
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

1

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 8:
Comparator MABTHERA 500 mg concentrado para solución para per
ROCHE REGISTRATION LIMITED
Solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

20

Concentración del fármaco:

mg milligram(s) equal

500

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:

No hay placebos asignados al ensayo

Información General



Linfomas y otros Síndromes Linfoproliferativos

Linfoma de células B grandes difusas del subtipo de células B no de centro germinal.


The primary objective is to determine the complete response (CR) rate following treatment with VR-CAP (VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone) or standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy in subjects with newly diagnosed non-germinal center B-like (non-GCB) diffuse large B-cell lymphoma (DLBCL).

The secondary objectives are to determine overall response rate (CR + partial response);determine duration of response (CR or PR);determine duration of CR; determine time to subsequent anti-lymphoma therapy; determine Kaplan-Meier estimates of 1- and 2-year progression-free survival rates; determine Kaplan-Meier estimates of 1- and 2-year overall survival rates; determine the safety profile of the VR-CAP regimen; correlate immunohistochemistry & gene expression profiling or quantitative reverse transcription polymerase chain reaction data to identify the non-GCB subtype of DLBCL; identify RNA-based signatures that correlate with response to drug treatment; assess the change in fatigue and patient utility scores for the VR-CAP and R-CHOP treatment groups; explore the measurement properties of the EORTC QLQ-C30 and the EQ-5D in this patient population; collect medical resource utilization data that may be used in future economic modeling

No


Potential subjects must satisfy all of the following criteria to be enrolled in the study:- Histologically confirmed non-GCB, de novo DLBCL- The histological confirmation of non-GCB DLBCL must be done centrally.Paraffin-embedded tissue blocks must be sent to the central laboratory forconfirmation of the non-GCB subtype by IHC prior to randomization- CD20+ disease- Stage II, III, or IV disease by the American Joint Committee on Cancer, NHL stagingsystem. Stage 1 primary mediastinal (thymic) DLBCL is also eligible.- At least 1 measurable site of disease based on the Revised Response Criteria for Malignant Lymphoma- Man or women, aged 18 years or older (must be at least the legal age limit to be able to give informed consent within the jurisdiction the study is taking place.)- Eastern Cooperative Oncology Group [ECOG] performance status of 0, 1, or 2- Absolute neutrophil count (ANC) 1,500 cells/L- Platelets 100,000 cells/L. Subjects with thrombocytopenia due to bone marrowinfiltration from DLBCL are eligible if platelets are 50,000 cells/L.- Alanine aminotransferase (ALT) 3 x upper limit of normal (ULN)- Aspartate aminotransferase (AST) 3 x ULN- Total bilirubin <2mg/dL, except in patients with Gilbert syndrome or in patients inwhom the bilirubin rise is of non-hepatic origin- Serum creatinine <1.5 x UNL or creatinine clearance 50 cc/min- Women must be:- postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months),- surgically sterile (have had a hysterectomy or bilateral oophorectomy, tuballigation, or otherwise be incapable of pregnancy),- abstinent (at the discretion of the investigator/per local regulations), or- if sexually active, be practicing a highly effective method of birth control(eg, prescription oral contraceptives, contraceptive injections, contraceptive patch,intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervicalcap, with spermicidal foam, cream, or gel, male partner sterilization) as localregulations permit, before entry, and must agree to continue to use the samemethod of contraception throughout the study. They must also be prepared tocontinue birth control measures for at least 6 months after terminating treatment.- Women of childbearing potential must have a negative serum or urine beta-humanchorionic gonadotropin (beta-hCG) pregnancy test at screening- Men must agree to use an acceptable method of contraception (for themselves orfemale partners as listed above) for the duration of the study. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug- Willing/able to adhere to the prohibitions and restrictions specified in this protocol- All subjects (or their legally-acceptable representatives) must have signed aninformed consent document indicating that they understand the purpose of andprocedures required for the study and are willing to participate in the study- To participate in the optional 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 thepharmacogenomic component of the study (where local regulations permit). Refusalto give consent for this component does not exclude a subject from participation inthe clinical study. Acquisition of tumor sample collections is required for all subjects;all other sample collections are optional.

Potential subjects who meet any of the following criteria will be excluded fromparticipating in the study:History of disallowed therapies:- Prior treatment with VELCADE- Transformed lymphomas (follicular, T-cell, or Hodgkin's lymphoma)- Prior extended radiotherapy for lymphoma (extended field radiotherapy such asmantle field radiation and inverted Y field radiation)- More than 150 mg/m2 of prior doxorubicin for any reason- Major surgery within 3 weeks before randomization- Prior chemotherapy for lymphomaShort course (maximum of 10 days; not exceeding 100 mg/day) prednisone or equivalent steroids are allowed to treat symptoms in subjects with advanced disease who entered the screening phase and are awaiting to be randomized.- Peripheral neuropathy or neuralgia of Grade 2 or worse- Active CNS lymphoma- Pregnant or breast feeding- Uncontrolled or severe cardiovascular disease, including myocardial infarction within6 months of enrollment, New York Heart Association (NYHA) Class III or IV heartfailure, uncontrolled angina, pericardial disease, cardiac amyloidosis,or left ventricular ejection fraction (LVEF) <45%- Diagnosed or treated for a malignancy other than NHL except: adequately treatednon-melanoma skin cancer, curatively treated in-situ cancer of the cervix, ductalcarcinoma in situ of the breast, or other solid tumors curatively treated with noevidence of disease for >5 years- Active systemic infection requiring treatment including active hepatitis B infection(carriers of hepatitis B are permitted to enter the study)- Documented or suspected human immunodeficiency virus (HIV)/AIDS? Known allergies, hypersensitivity, or intolerance to VELCADE, cyclophosphamide,rituximab, prednisone, doxorubicin, vincristine, or its excipients or compounds containing boron, mannitol, or similar agents- Serious medical condition, such as active peptic ulcer disease, acute diffuseinterstitial pulmonary disease, uncontrolled diabetes, or psychiatric illness, likely tointerfere with participation in this clinical study- Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is not excluded.- Any condition that, in the opinion of the investigator, would compromise thewell-being of the subject or the study or prevent the subject from meeting orperforming study requirements

The primary endpoint is CR, which is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms present before therapy in subjects with histologically-confirmed non-GCB DLBCL.

Fase II
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
Si

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
1
  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:


8

Para estudios internacionales:


66
164

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha