Hemotrial Un proyecto de SEHH

Ensayo clínico

ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO Y ABIERTO PARA DETERMINAR LA EFICACIA DE LENALIDOMIDA (REVLIMID®) FRENTE AL TRATAMIENTO DE ELECCIÓN DEL INVESTIGADOR EN PACIENTES QUE HAN RECIDIVADO O QUE SON RESISTENTES AL LINFOMA DE CÉLULAS DEL MANTO

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Resumen

2017-03-15 04:08:27
2008-003389-25
CC-5013-MCL-002
ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO Y ABIERTO PARA DETERMINAR LA EFICACIA DE LENALIDOMIDA (REVLIMID®) FRENTE AL TRATAMIENTO DE ELECCIÓN DEL INVESTIGADOR EN PACIENTES QUE HAN RECIDIVADO O QUE SON RESISTENTES AL LINFOMA DE CÉLULAS DEL MANTO
SPRINT
CC-5013-MCL-002

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. Lenalidomida
CC-5013 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 2:
Test REVLIMID 10 mg càpsulas 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 3:
Test REVLIMID 25 mg cápsulas duras
CELGENE EUROPE LTD.
Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

CC-5013 LENALIDOMIDA

Concentración del fármaco:

mg milligram(s) equal

20

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 2 mg, film coated tablet
The Wellcome Foundation
Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

CC-5013 CHLORAMBUCIL

Concentración del fármaco:

mg milligram(s) equal

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 5:
Comparator MABTHERA 500 mg concentrado para solución para per
ROCHE REGISTRATION LIMITED
Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

CC-5013 LENALIDOMIDA

Concentración del fármaco:

mg milligram(s) equal

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 6:
Comparator GEMZAR 1 g powder for solution for infusion
Eli Lilly and Company Limited
Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

CC-5013 LENALIDOMIDA

Concentración del fármaco:

mg milligram(s) equal

10
RITUXIMAB

Concentración del fármaco:

mg milligram(s) equal

2

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 7:
Comparator Fludarabine Phosphate 25 mg/ml concentrate for sol
Teva UK Ltd
Powder for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

GEMCITABINE HYD

Concentración del fármaco:

mg milligram(s) equal

500

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 Cytarabine 100 mg/ml Injection
Mayne Pharma Plc
Concentrate for solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

FLUDARABINE PHO

Concentración del fármaco:

g gram(s) equal

1

Concentración del fármaco:

mg/ml milligram equal

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 9:
Comparator Fludara oral 10 mg film coated tablet
Bayer Plc
Solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/ml milligram 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 10:
Comparator
Film-coated tablet
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
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Linfomas y otros Síndromes Linfoproliferativos

Linfoma de células del manto (LCM) recidivante o resistente


- To determine the tumor response of lenalidomide monotherapy or single agent of investigator?s choice in patients with mantle cell lymphoma (MCL) who have relapsed after or are refractory to at least 1 and up to 3 prior chemotherapy regimens.

- To evaluate the safety of lenalidomide monotherapy or single agent of investigator?s choice in patients with relapsed or refractory MCL.- To determine the time to progression, progression-free survival and overall survival of patients with relapsed or refractory MCL who have received treatment with lenalidomide or single agent of investigator?s choice.- To investigate the health-related quality of life (QoL) of patients treated with lenalidomide or investigator?s choice single agent treatment.

No


?Patients with histologically proven mantle cell non-Hodgkin?s lymphoma [MCL] {including overexpression of cyclin D1 by immunohistochemistry or t(11;14)(q13;q32) translocation by FISH analysis}. In patients whose tumors are negative for the cyclin D1 overexpression or translocation, evidence of overexpression of cyclin D2 or D3 by immunohistochemistry will be acceptable. ?Patients who have progressed, relapsed after or are refractory to at least one, and up to three prior chemotherapy regimens, and who have documented progressive disease. (Refractory to prior chemotherapy regimens is defined as not having reached a CR or PR to prior treatment.) ?Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2?Must be >18 years of age at the time of signing the informed consent form.?Must have had at least one prior combination chemotherapy regimen with an alkylating agent, and comprising either an anthracycline and/or cytarabine and/or fludarabine (with or without rituximab)?Prior stem cell transplant is allowed.?Must be ineligible for intensive chemotherapy and/or transplant at time of inclusion in the study?Must have measurable disease on cross sectional imaging by CT/MRI that is at least 2 cm in the longest diameter and measurable in two perpendicular dimensions ?Must be able to adhere to the study visit schedule and other protocol requirements?Life expectancy of greater than 3 months?Females of childbearing potential (FCBP) must:-Have a negative medically supervised pregnancy test prior to starting of study therapy. She must 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 ?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 to not donate semen during study drug therapy and for a period after end of study drug therapy?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 medication with another person.-Agree to be counseled about pregnancy precautions and risks of fetal exposure.

?Diagnosis of lymphoma other than mantle cell lymphoma?Prior history of malignancies, other than mantle cell lymphoma, 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 histological finding of prostate cancer (TNM stage of T1a or T1b)?Transformed lymphoma?Prior use of lenalidomide?Patients who are candidates for autologous or allogeneic transplantation at the time of inclusion in the study?Prior allogeneic transplantation with persistent donor hematopoiesis?Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible?Active CNS lymphoma with the exception of those patients whose CNS lymphoma has been treated with chemotherapy, radiotherapy or surgery, have remained asymptomatic for 90 days (3 months) and demonstrate no CNS lymphoma as shown by lumbar puncture, CT/brain MRI are eligible. Patients with a history of CNS involvement or CNS symptoms will be required to have negative CSF cytology examination and a head CT during the screening period (known and active CNS or leptomeningeal involvement). ?Patients who are not willing to take DVT prophylaxis?Patients should not be given continuous corticosteroids except prednisone (or equivalent) for the treatment of tumor flare. In addition, prednisone or equivalent up to 10 mg for purposes other than treatment of lymphoma is allowed.?Pregnant or lactating females?Any of the following laboratory abnormalities:-Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)-Platelet count < 60,000/mm3(60 x 109/L)-Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) 5.0 x upper limit of normal (ULN).-Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except in case of hemolytic anemia-Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min?Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.?Participation in another clinical trial during the screening/baseline phase and treatment phase of the study.

?Overall response rate (complete response [CR], complete response unconfirmed [CRu], and partial response [PR]) assessed by a modification of the International Lymphoma Workshop Criteria IWRC] (Cheson, 1999) [hereafter modified 1999 IWRC].

Fase II
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
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:

2
6
  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:


10

Para estudios internacionales:


140
150

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha