NCT01221103Unknown1 期
Phase I/II Trial of Dexamethasone, Ofatumumab and Bendamustine [Treanda] (DOT) as First-line Treatment of Mantle-cell Lymphoma (MCL) in the Elderly
Southern Europe New Drug Organization2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Adverse events (Phase I)
研究概览
简要总结
The rationale for this study design is based on the fact that the maximum tolerated dose (MTD) of single-agent ofatumumab and bendamustine have been previously determined. The choice of the doses for the combination is based on the investigators unpublished clinical experience, as well as inferred from extensive experimental data on the use of other monoclonal antibodies in combination chemotherapy in lymphoma patients. The starting dose of the 2 main component drugs is the MTD of each drug as single agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years.
- •ECOG Performance Status 0-
- •Life expectancy of at least 6 months.
- •Histological diagnosis of MCL (morphology, CD5+/CD20+ /CD23-, t(11:14) and/or cyclin D1 overexpression).
- •Disease requiring treatment (patients with bone marrow only disease, who are candidates for a watch-and-wait approach, will be excluded)
- •Adequate bone marrow, liver and renal function, unless the abnormality is related to the tumor and is unlikely to affect the safety of bendamustine and ofatumumab use. Adequate marrow and organ function will be assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •Hemoglobin ≥ 9.0 g/dL
- •Absolute neutrophil count (ANC) ≥ 1000/µl
- •Platelet count ≥ 75000/µl
- •Total bilirubin ≤ 1.5 times the ULN
- •AST and ALT ≤ 2.5 x ULN
- •Alkaline phosphatase ≤ 4 x ULN
- •Serum creatinine ≤ 2.5 x ULN
- •PT-INR/PTT < 1.5 x ULN [Patients who are being therapeutically anticoagulated with agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists]
- •Written informed consent.
排除标准
- •Previous treatment for mantle-cell lymphoma (MCL)
- •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, tuberculosis and active Hepatitis C.
- •Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
- •Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
- •History of significant cerebrovascular disease or event with significant symptoms or sequelae
- •Glucocorticoid use, unless given in doses ≤ 100 mg/day hydrocortisone (or equivalent dose of other glucocorticoid) for <7 days for exacerbations other than CLL (e.g., asthma)
- •Known HIV positive
- •Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
- •Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive and HBsAb negative, a HB DNA test will be performed and if positive the subject will be excluded. Note: If HBcAb positive and HBsAb positive, which is indicative of a past infection, the subject can be included.
- •Positive serology for hepatitis C (HC) defined by positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result.
- •Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to Visit 1, whichever is longer or currently participating in any other interventional clinical study
- •Known or suspected inability to comply with study protocol
- •History of organ allograft
- •Patients with evidence or history of bleeding diathesis.
- •Patients undergoing renal dialysis.
- •Substance abuse, medical psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- •Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
研究组 & 干预措施
DOT
Experimental
Combination of dexamethasone, ofatumumab and bendamustine
干预措施: Combination of dexamethasone, ofatumumab and bendamustine (Drug)
结局指标
主要结局
Adverse events (Phase I)
时间窗: 60 days after last dose of investigational drug
Incidence, severity, and attribution of treatment-emergent AEs
Complete Response rate (Phase II)
时间窗: 24 months
Response determined according to the revised response criteria for malignant lymphoma (Cheson, JCO 2008)
次要结局
- Duration of response (Phase II)(At the screening, cycle 4 (12 weeks) , cycle 6 (18 weeks), 1 year Follow-up)
- Serial peripheral blood CD34+ cell counts(Cycles 1 (3 weeks), 4 (12 weeks) and 6 (18 weeks))
- Molecular analysis of CD34+ cells(cycle 4 (12 weeks) or cycle 6 (18 weeks for inadequate harvests after cycle 4))
- Serial molecular analysis of peripheral blood cells(Cycles 1 (3 weeks), 4 (12 weeks) and 6 (18 weeks))
- Ability to harvest ≥ 7 x106 CD34+ cells/kg(Cycle 4 (12 weeks) or cycle 6 (18 weeks for inadequate harvests after cycle 4))
- Presence of tumor cells in the peripheral blood(Cycle 1 (3 weeks), 4 (12 weeks) and 6 (18 weeks))
研究者
研究点 (2)
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