Hemotrial Un proyecto de SEHH

Ensayo clínico

Ensayo clinico multicentrico, abierto, de un solo brazo, y de fase 2, con ofatumumab en pacientes con linfoma de celulas B grandes difuso (LCBGD) en recidiva no elegibles para trasplante o en recidiva tras trasplante autologoAn open-label, single-arm, multi-center phase 2 trial with ofatumumab in patients with relapsed Diffuse Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

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Resumen

2017-03-15 04:06:14
2007-004190-26
GEN415
Ensayo clinico multicentrico, abierto, de un solo brazo, y de fase 2, con ofatumumab en pacientes con linfoma de celulas B grandes difuso (LCBGD) en recidiva no elegibles para trasplante o en recidiva tras trasplante autologoAn open-label, single-arm, multi-center phase 2 trial with ofatumumab in patients with relapsed Diffuse Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant
GEN415

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

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
Ofatumumab
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

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, Trasplante Hematopoyético

Linfoma de células B grandes difusoDiffuse Large B-Cell Lymphoma

To investigate the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after autologous transplant

To determine the safety and pharmacokinetic (PK) profile of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after autologous transplant

No


1. Patients with relapsed DLBCL and ineligible for stem cell transplantation or relapsed DLBCL after autologous stem cell transplantation2. Tumor verified to be CD20+ positive from excisional or incisional lymph node biopsy.3. 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 cm4. ECOG Performance Status of 0, 1, or 25. Age ? 18 years6. Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out

1. More than 1 previous radioimmunotherapy regimen2. Received radioimmunotherapy within 3 months prior to Visit 23. Received any of the following treatments within 4 weeks prior to Visit 2:a. Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues)b. Glucocorticoid unless given in doses equivalent to ? 10 mg of prednisolone /day4. Received monoclonal antibodies, other than rituximab, within 3 months prior to Visit 25. Patients previously treated with other anti-CD20 monoclonal antibodies than rituximab, tositumomab and ibritumomab tiuxetan (the latter two in accordance with exclusion criteria no.1 and 2)6. Patients with previously diagnosed and treated indolent lymphoma7. Known CNS involvement of DLBCL8. Past or current malignancy, except for:a. Cervical carcinoma Stage 1B or lessb. Non-invasive basal cell and/or squamous cell skin carcinomac. Malignant melanoma with a complete response of a duration of < 10 yearsd. Other cancer diagnoses with a complete response of a duration of < 5 years9. 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 C10. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure (NYHA III-IV), and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities11. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease12. History of significant cerebrovascular disease13. Known HIV positive14. Positive serology for hepatitis B (HB) defined as:a. Positive test for HBsAg and/orb. Positive test for anti-HBs and anti-HBcPatients with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will not be considered positive.15. Screening laboratory values:a. platelets < 50 x 10^9/L (unless due to DLBCL involvement of the bone marrow)b. neutrophils < 1.0 x 10^9/L (unless due to DLBCL involvement of the bone marrow)c. creatinine > 2.0 times upper normal limit (unless normal creatinine clearance)d. total bilirubin > 1.5 times upper normal limit (unless due to liver involvement of DLBCL)e. ALT > 2.5 times upper normal limit (unless due to liver involvement of DLBCL)f. alkaline phosphatase > 2.5 times upper normal limit (unless due to liver involvement of DLBCL)16. Known or suspected hypersensitivity to components of investigational product 17. Life expectancy less than 6 months18. Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 219. Current participation in any other interventional clinical trial20. Patients known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)21. Breast feeding women or women with a positive pregnancy test at Visit 122. Women of childbearing potential not willing to use adequate contraception during trial and one year after last dose of ofatumumab. 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 with ofatumumab assessed according to the “Revised response criteria for malignant lymphoma"

Fase II
  DISEÑO DEL ENSAYO:

No
No

Si
No

No
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

Si

Centros participantes:

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

5
9
  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:

Para estudios internacionales:

70
75

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 EC Finalizado



EC Finalizado

Inicial