NCT00338494已完成1 期
Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermed.Grade B-Cell/T-Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- determine the overall response rate, plus partial response of clofarabine
研究概览
简要总结
Clofarabine is a new chemotherapy drug which was FDA approved for the treatment of acute lymphocytic leukemia in children. This study is being done to see if Clofarabine works in adult patients with B-cell types of lymphoma.
This research is being done to develop new treatments for patients with lymphoma whose cancer has returned or resisted treatment with previous chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who are at least 18 years old
- •Histologically confirmed low grade or intermediate-grade B-cell lymphoma
- •Relapsed or refractory to at least one standard chemotherapy regimen. Patients who have received Rituximab alone without having received a cytotoxic agent are not eligible.
- •Measurable disease, defined by the Cheson lymphoma criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Life expectancy greater than 12 weeks
- •Laboratory values obtained ≤2 weeks prior to entry
- •Absolute neutrophil count (ANC) ≥ 1000 x 10 9/L
- •White blood cell (WBC) count > 2.5 x 10 9/L
- •Platelets ≥ 75 x 10 9/L
- •Hemoglobin (Hg) > 9.0 g/dL
- •Total bilirubin ≤2.0 mg/dL
- •Aspartate transaminase (AST)/alanine transaminase (ALT) ≤3 × upper limit of normal (ULN)
- •Serum creatinine ≤2.0 mg/dL
- •Normal cardiac function, defined as an ejection fraction ≥45% determined by pretreatment radionuclide ventriculography (RVG) or echocardiogram.
- •Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
- •Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
- •Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
排除标准
- •Previously untreated B-cell lymphoma.
- •Received previous treatment with clofarabine.
- •Patients with known AIDS-related or HIV-positive lymphoma.
- •Autologous bone marrow or stem cell transplant within 6 months of study entry.
- •Prior radiotherapy to the only site of measurable disease.
- •Any medical condition that requires chronic use of oral high-dose corticosteroids greater than 20 mg/day prednisone.
- •Active autoimmune thrombocytopenia.
- •Use of investigational agents within 30 days or any anticancer therapy within 3 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy.
- •Patients with an active, uncontrolled systemic infection considered to be opportunistic, life threatening, or clinically significant at the time of treatment or with a known or suspected fungal infection (ie, patients on parenteral antifungal therapy).
- •Active secondary malignancy.
- •Pregnant or lactating patients.
- •Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
- •Patients with active or untreated central nervous system (CNS) lymphoma.
研究组 & 干预措施
1
Experimental
干预措施: Clofarabine (Drug)
结局指标
主要结局
determine the overall response rate, plus partial response of clofarabine
时间窗: upon completion of the study
tolerated dose (MTD) of clofarabine
时间窗: at the completion of dose escalation
characterize and quantify the toxicity profile associated with clofarabine
时间窗: upon completion of the study
次要结局
未报告次要终点
研究者
研究点 (1)
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