EUCTR2008-004177-17-GB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
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
- 性别
- All
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, marginal
- •zone lymphoma, and follicular lymphoma; grades 1, 2 and 3A, defined
- •according to World Health Organization guidelines. Subjects with a diagnosis
- •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 rituximab-containing
- •regimen (See Section 6.2.5.4– Section 6.2.5.5 of study protocol for details on response criteria),
- •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 study-specific
- •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 study:
- •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 lymphoma
- •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 non-melanoma 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 109/L (unless due to indolent lymphoma involvement of
- •the bone marrow)
- •? Serum creatinine > 1.5 times the institution’s upper limit of normal (ULN);
- •subjects with a serum creatinine > 1.5 ULN will be eligible if the calculated
- •creatinine clearance [Cockcroft, 1976] or creatinine clearance from a 24-
- •hour urine collection is ? 40 mL/min
- •? Total bilirubin > 1.5 times ULN (unless due to liver involvement by FL or
- •Gilbert’s disease)
- •? Transaminases > 3 times ULN
- 另有 2 项未显示
研究者
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