Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio doble ciego, aleatorizado, con dos grupos de dosis en paralelo, internacional y multicéntrico de HuMax-CD20, un anticuerpo monoclonal totalmente humano anti-CD20, en pacientes con Linfoma Folicular resistentes a rituximab en combinación con quimioterapia

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Resumen

2017-03-15 03:59:16
2006-001433-17
Hx-CD20-405
Estudio doble ciego, aleatorizado, con dos grupos de dosis en paralelo, internacional y multicéntrico de HuMax-CD20, un anticuerpo monoclonal totalmente humano anti-CD20, en pacientes con Linfoma Folicular resistentes a rituximab en combinación con quimioterapia
HuMax-CD20 in FL patients refractory to rituximab
Hx-CD20-405

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Genmab A/S Denmark

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
HuMax-CD20
HuMax-CD20 Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):
HuMax-CD20

Concentración del fármaco:
mg/ml milligram equal

20

Contenido del fármaco

No
Si

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

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

Non-Hodgkin Follicular Lymphoma

To determine the efficacy in two dose regimens of HuMax-CD20 in patients with Follicular Lymphoma who are refractory to rituximab in combination with chemotherapy.

To determine the long-term efficacy, the safety and the pharmacokinetic profile in two dose regimens of HuMax-CD20.

No


1) Patient with follicular lymphoma grade 1 – 2 (defined according to WHO guidelines)2) Refractory to rituximab in combination with chemotherapy (e.g. R-F, R-CVP, R-CHOP, R-FM, R-FCM), or to rituximab given as maintenance treatment, is defined as: a. failure to achieve at least PR to rituximab in combination with chemotherapy;or,b. disease progression while on rituximab (either in combination with chemotherapy or during rituximab maintenance treatment); or,c. disease progression in responders within 6 months of the last dose of rituximab (either in combination with chemotherapy or after rituximab maintenance treatment schedule)3) Tumor verified to be CD20+ positive from excisional lymph node biopsy . The excisional lymph node biopsy has to be redone if: no tissue is available for central review or if there is clinical suspicion that the follicular lymphoma has transformed to aggressive lymphoma/higher malignancy grade4) CT scan in screening phase (based on local evaluation) showing:a. 2 or more clearly demarcated lesions with a largest diameter ? 1.5 cm, orb. 1 clearly demarcated lesion with a largest diameter ? 2,0 cm5) ECOG Performance Status of 0, 1, or 26) Age ? 18 years7) Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out

1) Previous autologous stem cell transplantation, within 6 months prior to Visit 12) Previous allogeneic stem cell transplantation3) More than 1 previous radio immunotherapy regimen4) Received radio immunotherapy within 3 months prior to Visit 15) Received any of the following treatments within 4 weeks prior to Visit 1:• Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues)• Glucocorticoid unless given in doses equivalent to ? 10 mg of prednisolone /day6) Received monoclonal antibodies, other than rituximab, within 3 months prior to Visit 17) Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab8) Clinical suspicion that the follicular lymphoma transformed to aggressive lymphoma (e.g. B-symptoms, fast growing tumor or increasing LDH level) unless a new biopsy, just before study entry, confirms follicular lymphoma9) Known or suspected CNS involvement of FL10) Past or current malignancy, except for:• Follicular Lymphoma• Cervical carcinoma Stage 1B or less• Non-invasive basal cell and squamous cell skin carcinoma• Malignant melanoma with a complete response of a duration of > 10 years• Other cancer diagnoses with a complete response of a duration of > 5 years11) Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C12) Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities13) Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease14) History of significant cerebrovascular disease15) Known or suspected HIV positive16) Positive serology for hepatitis B17) Screening laboratory values:• CD20 positive circulating lymphoma cells >10 x 10E9/L• platelets < 50 x 10E9/L• neutrophils < 1.0 x 10E9/L • creatinine > 1.5 times upper normal limit (unless normal creatinine clearance) • total bilirubin > 1.5 times upper normal limit (unless due to liver involvement of FL) • ALT > 2.5 times upper normal limit (unless due to liver involvement of FL) • alkaline phosphatase > 2.5 times upper normal limit (unless due to liver involvement of FL)18) Known or suspected hypersensitivity to components of investigational product19) Patients with pleural effusion or ascites of significant degree, defined as detectable by physical examination20) Life expectancy less than 6 months21) Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 122) Current participation in any other interventional clinical study23) Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)24) Breast feeding women or women with a positive pregnancy test at Visit 125) Women of childbearing potential not willing to use adequate contraception during study and one year after last dose of HuMax-CD20. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double barrier method is also considered adequate.

Objective response as measured over a 6 month period from start of treatment assessed by an Independent endpoints Review Committee (IRC) according to the standardized response criteria for Non-Hodgkin’s Lymphomas.

Fase III
  DISEÑO DEL ENSAYO:

No
Si

No
No

No
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

No
No

Si

Centros participantes:

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

5
  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:

15

Para estudios internacionales:

150
162

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 EC Finalizado



EC Finalizado

Inicial