B-cell Chronic Lymphocytic Leukemia MedDRA version: 7.0 Level: LLT Classification code 10008959
Conditions
Interventions
Product Name: HuMax-CD20
Product Code: HuMax-CD20
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ofatumumab
CAS Number:
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Tumor cell phenotype consistent with B-CLL: CD5, CD20, CD23 2) Patients with active B-CLL and with an indication for treatment, defined as presenting one of the following conditions as defined by the NCIWG guidelines (1): a. evidence of progressive marrow failure as manifested by development of, or worsening of anemia or thrombocytopenia; or, b. massive (= 6 cm below the left costal margin) or progressive splenomegaly; or, c. massive nodal clusters (= 10 cm in longest diameter) or progressive lymphadenopathy; or, d. progressive lymphocytosis with an increase of > 50% over a two month period or an anticipated doubling time 5 cm requiring therapy 5) ECOG Performance Status of 0, 1 or 2 6) Life expectancy of at least 6 months 7) Age = 18 years 8) 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 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Previous treatment with alemtuzumab within 6 weeks prior to Visit 2 2) Previous autologous stem cell transplantation within 6 months prior to Visit 2 3) Allogeneic stem cell transplantation 4) Radioimmunotherapy 5)Received any of the following treatments within 4 weeks prior to Visit 2: Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies), Glucocorticoid unless given in doses equivalent to = 10 mg of prednisolone /day, Leukapheresis 6) Patients previously treated with HuMax-CD20 7) Known Richter transformation of B-CLL 8) Known CNS involvement of B-CLL 9) Past or current malignancy, except for: 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 years 10) 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 11) 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 abnormalities 12) Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease 13) History of significant cerebrovascular disease 14) Known HIV positive 15) Positive serology for hepatitis B, defined as a positive test for HBsAg and/or a combination of a positive test for anti-HBs and anti-HBc 16) Removed by Amendment 2 17) Known or suspected hypersensitivity to components of investigational product 18) Patients with pleural effusion or ascites of significant degree, defined as detectable by physical examination 19) ECOG Performance Status of 3 or 4 20) Life expectancy less than 6 months 21) Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 2 22) Current participation in any other interventional clinical study 23) 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 1 25) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of HuMax-CD20 in patients with B-cell Chronic Lymphocytic Leukemia (B-CLL) who have failed fludarabine and alemtuzumab; Secondary Objective: To determine the safety of HuMax-CD20 (ofatumumab) To determine the host immune response to HuMax-CD20 (ofatumumab) To determine the pharmacokinetic profile of HuMax-CD20 (ofatumumab) ;Primary end point(s): Objective response as measured over a 24 week period from start of treatment assessed by an Independent endpoints Review Committee (IRC), according to the NCIWG guidelines. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed