A Study Comparing MK-8808 to MabThera™ in Patients with Advanced Follicular Lymphoma.
- Conditions
- Previously untreated patients with CD20-positive follicular lymphoma, Grade 1, 2 or 3a according to the WHO 2008 classification system.MedDRA version: 14.1 Level: LLT Classification code 10059432 Term: Follicular mixed small and large cell lymphoma System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004190-12-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 520
1. Patient understands the study procedures, alternative treatments available, the risks involved with the study, and agrees to participate by giving informed consent. 2. Patient is male or female, and =18 years of age on the day of signing informed consent. 3. Patient has a life expectancy >3 months with no expected need of immediate intervention to treat life threatening complications. 4. Patient has a histological diagnosis of CD20-positive follicular lymphoma, Grade 1, 2 or 3a according to the WHO 2008 classification system (see Appendix 6.3), the biopsy must be comprised of <50% diffusearchitectural pattern (i.e., the follicular pattern component must be 50%), and areas of diffuse architecture may not show histological characteristics of diffuse large B-cell lymphoma. A surgical lymph node excision or biopsy is highly preferred as tissue source for pathological diagnosis. A core needle biopsy is acceptable if there are no palpable peripheral lymph nodes available for surgical excision or biopsy. A core needle biopsy requires a minimum needle size of 16 gauge. A bone marrow aspirate or biopsy is not acceptable for the sole diagnosis of FL in this study. 5. Patient has Ann Arbor Stage III or IV (See Appendix 6.4) and, in the opinion of the investigator, patient requires chemo immunotherapy. Common reasons for initiation of chemo-immunotherapy include (but are not exclusive to): - Rapid clinical lymphoma progression - Bulky disease (e.g., nodal or extranodal mass >6 cm in its greatest diameter) - Symptomatic enlargement of spleen or liver Vital organ compression - Ascites or pleural effusion - Cytopenia secondary to lymphoma - B symptoms (e.g. fever >38°C without infection; drenching night sweats; unexplained loss of >10% body weight within the preceding 6 months) 6. Patient has at least one bi-dimensionally measureable lesion and that lesion must not have been previously irradiated. 7. Patient has Eastern Cooperative Oncology Group (ECOG) performance status =2 (see Appendix 6.2). 8. Female patients of childbearing potential (defined as women who have not been surgically sterilized or have not been free from menses for > 2 years) have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 206
1. Number of circulating lymphatic cells >10,000/mcL. 2. Presence or history of CNS involvement (either CNS lymphoma or lymphomatous meningitis). 3. Prior systemic therapy for FL, including but not limited to chemotherapy, anti- CD20 compounds, immunotherapy and any other type or class of anti-cancer drugs. 4. Prior therapy with an anthracycline (e.g., doxorubicin, epirubicin, liposomal doxorobucin). 5. Radiotherapy within 2 months prior to Cycle 1 Day 1, except involved field irradiation of up to two lesions that will not be used to evaluate disease progression. 6. Patient has a known hypersensitivity to any of the drugs required in this study or to any of the excipients or to murine proteins. 7. Patient with a history of a prior malignancy, with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; or who has undergone therapy with curative intent with no evidence of disease recurrence for five years. 8. Patient is currently participating or has participated in a study with an investigational compound within 30 days prior to Cycle 1 Day 1. 9. Patient has any medical contra-indication for prednisone as being dosed in the CHOP chemotherapy regimen. 10. Patient is in a severely immunocompromised state. 11. Patient has poorly controlled diabetes mellitus. 12. Patient has Grade =2 peripheral neuropathy. 13. Patient has one of the following: a. Is HIV-positive b. Is positive for Hepatitis B surface antigen (HBsAg+) or antibodies to Hepatitis B core antigen (anti-HBcAg+) c. Has antibodies to Hepatitis C virus 14. Patient has an active infection, including but not limited to tuberculosis. 15. Patient has severe cardiovascular disease, cardiac heart failure, unstable cardiovascular conditions including recent myocardial infarction, angina, arrhythmias or uncontrolled hypertension.
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