Ofatumumab in Diffuse Large B-Cell NHL

An open-label, single-arm multi-center phase 2 trial with ofatumumab in patinets with relapsed Diffuse Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

1. Patients with relapsed DLBCL and ineligible for stem cell transplantation or relapsed DLBCL after autologous stem cell transplantation
2. Tumor verified to be CD20+ from excisional or incisional lymph node biopsy
3. CT scan in screening phase (based on local evaluation) showing:- 2 or more clearly demarcated lesions with a largest diameter greater or equal to 1.5cm, or 1 clearly demarcated lesion with a largest diameter greater or equal to 2cm
4. ECOG performance status of 0,1, or 2
5. Age 18 years or over
6. 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 regimen
2. Received radioimmunotherapy within 3 months prior to visit2
3. Received any of the following treatments within 4 weeks prior to visit 2 - anti-cancer therapy, glucocorticoid unless given in doses equivelent to 10mg (equal or less) of prednisolone a day
4. Received monoclonal antibodies, other than riuximab, within 3 months prior to visit 2
5. Patients previously treated with other ant i- CD20 monoclonal antibodies than riuximab, tositumomab tiuxetan (the latter two in accordance with exclusion criteria No1 and 2
6. Patients with previously diagnosed and teated indolent lymphoma
7. Know CNS involvement of DLBCL
8. Past or current malignancy, except for - cervical carcinoma stage 1B or less, Non-invasive basal cell and/or squamous cell carcinoma, malignant melenoma with a complete response of a duration of less than 10 years, other cancer diagnosis with a complete response of a duration of less than 5 years
9. Chronic or ongoing active infectious disease including requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C.
10. Clinically significant cardiac disease including unstable angina, acute myocardial infarction with six months from visit 1, congestive heart failure (NYHA III-IV), and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities.
11. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
12. History of significant cerebrovascular disease
13. Known HIV positive
14. Positive serology for hepatitis B (HB) defined as: Positive test for HBsAg and/or Positive test for anti-HBs and anti-HBc. Patients with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will not be considered positive.
15. Screening lab values: Platelets < 50 x 10/9/L (unless due to DLBCL involvement of the bone marrow).  Neutrophils < 1.0 x 10/9/L (unless due to DLBCL involvement of the bone marrow).  Creatinine > 2.0 times upper normal limit (unless normal creatinine clearance).  Total bilirubin > 1.5 times upper normal limit (unless due to liver involvement of DLBCL).  ALT > 2.5 times upper normal limit (unless due to liver involvement  of DLBCL).  Alk Phos > 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 months
18. Patients who have received tratment wiht any non-marketed drug substance or experimental therapy within 4 weeks prior to visit 2
19. Currents participation in any other interventional clinical trial
20. 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. Breat feedinig women or women with a positive pregnacy test at visit 1
22. Women of cheldbearing potential not willing to use adequate contraception during trial oand 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.

Research Nurse

David Buchanan

Tel 0113 3922879

Email david.buchanan@leedsth.nhs.uk

Principal Investigaror

Dr Rod Johnson

Tel 0113 2068369

Email rod.johnson@leedsth.nhs.uk

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