EUCTR2008-004177-17-PL进行中（未招募）1 期
A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared with Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin’s Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 346
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Subjects eligible for enrollment in the study must meet all of the
- •following criteria:
- •1. Small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma,
- •zone lymphoma, and follicular lymphoma; grades 1, 2 and 3A, defined
- •according to World Health Organization guidelines. Subjects with a
- •of SLL who have a peripheral blood monoclonal B lymphocyte count of
- •=5,000/µL are considered to have CLL and are not eligible for this study.
- •Tumor verified to be CD20+ positive from a previous or current tissue
- •CT imaging in screening phase (based on local evaluation) showing 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 (Section 6.2.5 of Study Protocol). CT imaging performed at screening as baseline image.
- •2. Indolent B-cell NHL with failure to achieve at least a partial response
- •lasting 6 months beyond the end of treatment with rituximab or a rituximabcontaining regimen (See Section 6.2.5.4– Section 6.2.5.5 of study protocol for details on response criteria), i.e.:
- •Stable disease (SD) after rituximab or a rituximab-containing regimen
- •(imaging will support this finding. NOTE: in cases of SD after rituximab
- •monotherapy as induction treatment, the minimum time to confirm SD
- •by imaging is 60 days from start of first rituximab infusion) or,
- •Disease progression during or within 6 months of treatment with
- •rituximab or a rituximab-containing regimen. Imaging must support this
- •finding and will be done = 6 months after the last infusion of rituximab.
- •Note: Subjects must have received a minimum of 4 rituximab infusions
- •as monotherapy or 3 infusions as part of rituximab-containing
- •combination regimens
- •3. ECOG Performance Status of 0, 1, or 2
- •4. Age = 18 years
- •5. Life expectancy of at least 6 months
- •6. Signed written informed consent prior to performing any studyspecific procedures
- •French subjects: In France, a subject will be eligible for inclusion in this
- •study only if either affiliated to or a beneficiary of a social security category
- •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 137
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •Subjects meeting any of the following criteria will not be enrolled in the
- •1. Grade 3b FL or evidence that the indolent lymphoma has transformed to aggressive lymphoma as verified by biopsy confirmation
- •2. Previous autologous stem cell transplant in the last 6 months or
- •previous allogeneic stem cell transplant at any time.
- •3. High dose steroids = 25 mg prednisolone/day (or equivalent) for 7
- •consecutive days, given as concomitant medication, within 3 months prior to randomization. No more than 10 mg prednisone daily at the time of randomization
- •4. Prior bendamustine treatment within 1 year of randomization not
- •resulting in a CR or PR for at least 6 months
- •5. Prior use of any monoclonal antibody (other than anti-CD20) within 3
- •months prior to randomization
- •6. Known central nervous system (CNS) involvement by indolent
- •7. Other past or current malignancy. Subjects who have been free of
- •malignancy for at least 5 years, or have a history of definitively treated nonmelanoma skin cancer, or successfully treated in situ carcinoma, are eligible*
- •8. Chronic or current active infectious disease requiring systemic
- •antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, and active Hepatitis C
- •9. Clinically significant cardiac disease as judged by the investigator
- •including unstable angina, acute myocardial infarction within 6 months of randomization, congestive heart failure, and arrhythmia requiring therapy
- •10. History of significant cerebrovascular disease or event with
- •significant symptoms or sequelae
- •11. Significant concurrent, uncontrolled medical condition that in the
- •opinion of the investigator or GSK medical monitor contraindicates
- •participation this study
- •12. Positive serology for Hepatitis B (HB) defined as a positive test for
- •Hepatitis B surface antigen (HbsAg). In addition, if negative for HBsAg but Hepatits B core antibody (HBcAb) positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded
- •? Consult with a physician experienced in care and management of
- •subjects with Hepatitis B to manage/treat subjects who are anti-HBc positive
- •? If HBV DNA is negative, subject may be included but must undergo HBV DNA monitoring (see Section 6.5.7.1 of study protocol). Prophylactic antiviral therapy may be initiated at the discretion of the investigator
- •13. Current active liver or biliary disease (subjects with Gilbert's
- •syndrome or asymptomatic gallstones, liver metastases related to indolent NHL or otherwise stable chronic liver disease per investigator assessment, are eligible)
- •14. Known human immunodeficiency virus (HIV) positive
- •15. Screening laboratory values:
- •? platelets < 100 x 109/L (unless due to indolent lymphoma involvement
- •of the bone marrow)
- •? neutrophils < 1.5 x 1
研究者
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