Hemotrial Un proyecto de SEHH

Ensayo clínico

ESTUDIO FASE 3, MULTICÉNTRICO, ALEATORIZADO, ABIERTO Y DE GRUPOS PARALELOS PARA VALORAR LA EFICACIA Y SEGURIDAD DE LENALIDOMIDA (REVLIMID®) FRENTE A CLORAMBUCILO COMO TERAPIA DE PRIMERA LÍNEA EN PACIENTES ANCIANOS CON LEUCEMIA LINFOCÍTICA CRÓNICA DE CÉLULAS B NO TRATADOS PREVIAMENTE (ENSAYO ORIGIN) //A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) VERSUS CHLORAMBUCIL AS FIRST-LINE THERAPY FOR PREVIOUSLY UNTREATED ELDERLY PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA(THE ORIGIN TRIAL)

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Resumen

2017-03-15 04:08:23
2008-003079-32
CC-5013-CLL-008
ESTUDIO FASE 3, MULTICÉNTRICO, ALEATORIZADO, ABIERTO Y DE GRUPOS PARALELOS PARA VALORAR LA EFICACIA Y SEGURIDAD DE LENALIDOMIDA (REVLIMID®) FRENTE A CLORAMBUCILO COMO TERAPIA DE PRIMERA LÍNEA EN PACIENTES ANCIANOS CON LEUCEMIA LINFOCÍTICA CRÓNICA DE CÉLULAS B NO TRATADOS PREVIAMENTE (ENSAYO ORIGIN) //A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) VERSUS CHLORAMBUCIL AS FIRST-LINE THERAPY FOR PREVIOUSLY UNTREATED ELDERLY PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA(THE ORIGIN TRIAL)
THE ORIGIN TRIAL
CC-5013-CLL-008

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Celgene Corporation United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test REVLIMID 5 mg cápsulas duras
CELGENE EUROPE LTD. Lenalidomide
CC-5013 Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

CC-5013 LENALIDOMIDA

Concentración del fármaco:

mg milligram(s) equal

1.25

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 2:
Test REVLIMID 10 mg càpsulas duras
CELGENE EUROPE LTD. Lenalidomide
CC-5013 Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

CC-5013 LENALIDOMIDA

Concentración del fármaco:

mg milligram(s) equal

2.5

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 3:
Test REVLIMID 15 mg cápsulas duras
CELGENE EUROPE LTD.
Capsule, hard
Oral use

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:
Test Leukeran Tablets 2 mg
GlaxoSmithKline GmbH & Co. KG
Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

10

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:
Test
Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

LENALIDOMIDA

Concentración del fármaco:

mg milligram(s) equal

5

Concentración del fármaco:

mg milligram(s) equal

15

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 6:
Comparator
Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

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
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Linfomas y otros Síndromes Linfoproliferativos

TERAPIA DE PRIMERA LÍNEA EN PACIENTES ANCIANOS CON LEUCEMIA LINFOCÍTICA CRóNICA DE CÉLULAS B NO TRATADOS PREVIAMENTE(FIRST-LINE THERAPY FOR PREVIOUSLY UNTREATED ELDERLY PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA)


To compare the efficacy of lenalidomide versus chlorambucil as first-line therapy in elderly patients

To evaluate the safety of lenalidomide versus chlorambucil as first-line therapy in elderly patients

No


1.Must understand and voluntarily sign an informed consent form.2.Age ? 65 years at the time of signing the informed consent form.3.Must be able to adhere to the study visit schedule and other protocol requirements.4.Must have a documented diagnosis of B-cell CLL [IWCLL guidelines for diagnosis and treatment of CLL ] meeting at least one of the following criteria:?Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia?Massive (i.e. > 6 cm below the left costal margin) or progressive or symptomatic splenomegaly?Massive nodes (i.e. > 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy?Progressive lymphocytosis with an increase of > 50% over a 2 month period, or lymphocyte doubling time (LDT) of less than 6 months?A minimum of any one of the following disease-related symptoms must be present:Unintentional weight loss ? 10% within the previous 6 monthsSignificant fatigue (i.e., ECOG PS 2; cannot work or unable to perform usual activities)Fevers of greater than 100.5° F or 38.0° C for 2 or more weeks without other evidence of infectionNight sweats for more than 1 month without evidence of infection5.Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ?2.6.Females of childbearing potential (FCBP) must:?Have a negative medically supervised pregnancy test prior to starting of study therapy and agree to ongoing pregnancy testing during the course of the study and after end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.?Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy. 7.Male patients must:?Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.?Agree not to donate semen during study drug therapy and for a period after end of study drug therapy.8.All patients must:?Have an understanding that the study drug could have a potential teratogenic risk.?Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.?Agree not to share study drug with another person.?All patients must be counseled about pregnancy precautions and risks of fetal exposure: Education and Counseling Guidance Document.

1.Prior treatment for B-cell CLL.2.Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.3.Active infections requiring systemic antibiotics.4.Systemic infection that has not resolved > 2 months prior to initiating study treatment in spite of adequate anti-infective therapy5.Pregnant or lactating females.6.Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating study therapy.7.Known presence of alcohol and/or drug abuse.8.Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging. Patients who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization.9.Prior history of malignancies, other than CLL, unless the patient has been free of the disease for ?3 years. Exceptions include the following:?Basal cell carcinoma of the skin?Squamous cell carcinoma of the skin?Carcinoma in situ of the cervix?Carcinoma in situ of the breast?Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)10.History of renal failure requiring dialysis.11.Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.12.Prior therapy with lenalidomide.13.Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (patients may be enrolled upon correction of electrolyte abnormalities).14.Any of the following laboratory abnormalities:?Calculated (method of Cockroft-Gault) creatinine clearance of <30 mL/min?Absolute neutrophil count (ANC) < 1,000/?L (1.0 X 109/L)?Platelet count < 50,000/?L (50 X 109/L) ?Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 5 x upper limit of normal (ULN)?Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert?s syndrome. 15.Uncontrolled hyperthyroidism or hypothyroidism16.Venous thromboembolism within one year 17.? Grade 2 neuropathy18.Uncontrolled autoimmune hemolytic anemia or thrombocytopenia19.Disease transformation [i.e. Richter?s Syndrome (lymphomas) or prolymphocytic leukemia]

Progression Free Survival (PFS)

Fase III
  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:

4
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:


48

Para estudios internacionales:


220
428

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha