A double-blind, randomized, two-dose-arm, parallel group, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with Follicular Lymphoma who are refractory to rituximab as monotherapy or in combination with chemotherapy - HuMax-CD20 in FL patients refractory to rituximab
- Conditions
- on-Hodgkin Follicular LymphomaClassification code 10003899
- Registration Number
- EUCTR2006-001433-17-DE
- Lead Sponsor
- Glaxo SmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1) Patient with follicular lymphoma grade 1 – 2 (defined according to WHO guidelines (World Helath Organization classification of tumours: pathology and genetics of tumours of haematopietic and lymphoid tissues)
2) Refractory to rituximab given as monotherapy or in combination with any chemotherapy or to rituximab given as maintenance treatment following R-chemo defined as:
a. failure to achieve at least PR to rituximab given as monotherapy or in combination with any chemotherapy; or,
b. disease progression while on rituximab (either given as monotherapy or in combination with any chemotherapy or during rituximab maintenance treatment following R-chemo); or,
c. disease progression in responders within 6 months of the last dose of rituximab (either given as monotherapy or in combination with any chemotherapy or after rituximab maintenance treatment schedule following R-chemo)
Please note that patients should have received at least 4 infusions of rituximab (either given as monotherapy or in combination with any chemotherapy)
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 grade
4) 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
5) ECOG Performance Status of 0, 1, or 2
6) Age = 18 years
7) 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
1)Previous autologous stem cell transplantation, within 6 months prior to Visit 2
2)Previous allogeneic stem cell transplantation
3)More than 1 previous radio immunotherapy regimen
4)Received radio immunotherapy within 3 months prior to Visit 2
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)
•Glucocorticoid unless given in doses equivalent to = 10 mg of prednisolone /day
6)Received monoclonal antibodies, other than rituximab, within 3 months prior to Visit 2
7)Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
8)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 lymphoma
9)Known CNS involvement of FL
10)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 years
11)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
12)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
13)Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
14)History of significant cerebrovascular disease
15)Known HIV positive
16)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
17)Screening laboratory values:
•platelets < 50 x 10^9/L (unless due to FL involvement of the bone marrow)
•neutrophils < 1.0 x 10^9/L (unless due to FL involvement of the bone marrow)
•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 hypersensitivity to components of investigational product
19)Patients with pleural effusion or ascites of significant degree, defined as:
a.Patients with ascites detectable by physical examination, or
b.Patients with pleural effusion detectable by physical examination unless due to lymphoma involvement or recent splenectomy
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 childbearin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method