Diffuse Large B-Cell Lymphoma MedDRA version: 17.0 Level: PT Classification code 10012821 Term: Diffuse large B-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Arzerra
Product Name: Ofatumumab
Product Code: HuMax-CD20
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Current Sponso
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with DLBCL: a. and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation b. and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation. 2. 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, or b. 1 clearly demarcated lesion with a largest diameter = 2.0 cm 4. ECOG Performance Status of 0, 1, or 2 5. Age = 18 years 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 31 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. More than 1 previous radioimmunotherapy regimen 2. Received radioimmunotherapy within 3 months prior to Visit 2 3. 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 /day 4. Received monoclonal antibodies, other than rituximab, within 3 months prior to Visit 2 5. 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 lymphoma 7. Known CNS involvement of DLBCL 8. Past or current malignancy, except for: a. Cervical carcinoma Stage 1B or less b. Non-invasive basal cell and/or squamous cell skin carcinoma c. Malignant melanoma with a complete response of a duration of > 10 years d. Other cancer diagnoses with a complete response of a duration of > 5 years 9. 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 C 10. 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 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: a. Positive test for HBsAg and/or b. 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 laboratory values: a. platelets 1.5 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 months 18. Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 2 19. Current 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. Breast feeding women or women with a positive pregnancy test at Visit 1 22. 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 considere
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of ofatumumab in patients with relapsed/progressive DLBCL ineligible for transplant or relapsed/progression after autologous transplant;Secondary Objective: To determine the safety and pharmacokinetic (PK) profile of ofatumumab in patients with relapsed/progressive DLBCL ineligible for transplant or relapsed/progression after autologous transplant;Primary end point(s): 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”;Timepoint(s) of evaluation of this end point: The primary endpoint is Objective Response (OR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of response, Progression Free survival, Overall survival, time to next DLBCL therapy, Adverse Events, HAHA, Pharmacokinetics;Timepoint(s) of evaluation of this end point: Objective Response (OR) measured over a 6 month period from the start of study treatment. Other endpoints measured at regular intervals over a 60 month period | — |
Countries
Belgium, Denmark, France, Italy, Romania, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Helpdesk
GlaxoSmithKline
Outcome results
None listed