Ofatumumab for the treatment of lymphomalease
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL) and grade 3b follicular lymphomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-009256-20-GB
- Lead Sponsor
- GlaxoSmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 447
Subjects eligible for enrolment in the study must meet all of the following criteria:
1. CD20 positive DLBCL or grade 3b follicular lymphoma (FL) at original diagnosis. If a biopsy or fine needle aspiration (FNA) is performed prior to enrolment to the study it must confirm CD20 positive DLBCL or grade 3b FL. Note: If evidence
emerges that the binding of the immunohistochemical antibody to CD20 can be blocked by rituximab, demonstration of CD20 positivity in the repeat biopsy/FNA will not be required.
2. Refractory to, or relapsed following, first-line treatment with rituximab concurrentlywith anthracycline-or anthracenedione based chemotherapy.
Relapse is defined as:
•Biopsy (preferred) or FNA confirmed DLBCL or grade 3b FL after a complete response (CR). However, for subjects relapsing during first-line treatment, biopsy/FNA reconfirmation of the lymphoma is recommended but not mandatory.
Subjects must have received rituximab concurrently with at least 6 cycles of chemotherapy. However, subjects with stage I/II disease will be eligible if they have received rituximab concurrently with at least 3 cycles of chemotherapy and definitive involved-field radiation therapy.
Refractory disease must fulfill one of the following:
•continuing partial response (PR) from termination of first-line treatment. The lymphoma should be reconfirmed by biopsy (preferred) or FNA, however, if these procedures are deemed to be inappropriate, then HOVON may determine eligibility following review of the imaging results and disease history.
Subjects must have received of rituximab concurrently with at least 6 cycles of chemotherapy. However, subjects with stage I/II disease will be eligible if they have received concurrently with at least 3 cycles of chemotherapy and definitive involved-field radiation therapy.
•continuing stable disease (SD) from termination of first-line treatment. Reconfirmation of the lymphoma by biopsy (preferred) or FNA is recommended but not mandatory.
Subjects must have received rituximab concurrently with at least 3 cycles of chemotherapy
•progressive disease (PD). Biopsy or FNA reconfirmation of the lymphoma is recommended but not mandatory.
Note: Disease response to first-line treatment should be determined according to Revised Response Criteria for Malignant Lymphoma [Cheson, 2007] or International Workshop Response criteria for NHL [Cheson, 1999].
3. Baseline FDG-PET scans must demonstrate positive lesions compatible with CT defined anatomical tumor
sites.
4. CT scan showing at least:
•2 or more clearly demarcated lesions/nodes with a long axis>1.5 cm and short axis >1.0 cm
OR
•1 clearly demarcated lesion/node with a long axis>2.0 cm and short axis >1.0 cm
5. Age =18
6. ECOG performance status 0, 1, or 2.
7. Eligible for high dose chemotherapy and ASCT.
8. Resolution of toxicities from first-line therapy to grade that in the opinion of the investig
Subjects meeting any of the following criteria must not be enrolled in the study:
1. Any previous cancer therapy for lymphoma, with the exception of:
• First-line treatment with rituximab and anthracycline or antracenedione-based chemotherapy.
•Monotherapy rituximab, dosed prior to first line rituximab combined with chemotherapy or as maintenance therapy
• Radiotherapy as part of the first-line treatment plan or to a limited field at a maximum dose of =10Gy to control
life-threatening symptoms.
2. Received any of the following treatments within 2 weeks prior to start of study therapy (unless otherwise stated):
• Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues)
• Radiotherapy unless it is to a limited field at a maximum dose of =10Gy to control life-threatening symptoms.
3. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study unless in the opinion of the investigator it does not contrainidicate particpation.
4. planned post randomised glucocorticoid, unless administered in doses =1mg/kg/day prednisolone (or equivalent dose of other glucocorticoid-refer to the SPM for glucocorticoid equivalent doses)
administered as inhalation therapy for mild COPD or asthma
5. History of significant cerebrovascular disease or event with significant symptoms or sequelae unless in the opinion of the investigator it does not contrainidicate participation
6. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomisation, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities unless in the opinion of the investigator it does not contraindicate participation
7. Significant concurrent, uncontrolled medical condition unless in opinion of the investigator it does not contraindicate participation
8. Known lymphoma involvement of the CNS.
9. Known or suspected hypersensitivity to study treatments that, in the opinion of the investigator , contraindicates their participation
10. Known HIV positivity.
11. Positive serology for hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
12. Active hepatitis C infections
13. Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis and tuberculosis.
14. Other past or current malignancy unless investigator considers it does not contrainidcate particip
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