A Pilot Study of Gleevec (Imatinib Mesylate) in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
The purpose of this research study is to evaluate the overall response rate to imatinib mesylate in participants with relapsed or refractory T cell non-Hodgkin's lymphoma. This drug has been used in chronic myeloid leukemia and information from those other research studies suggests that it may help to treat T cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary Objective To evaluate the overall response rate
Secondary Objectives To assess the safety and tolerability To assess the duration of response To assess the progression free survival and overall survival
STATISTICAL DESIGN:
This trial will use a single stage design to differentiate a >/= 25% response rate from a </= 5% rate. If observed data is consistent with the alternative response rate of 25%, imatinib would be deemed clinically interesting and worthy of a larger phase II study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed T NHL, excluding T prolymphocytic leukemia, T lymphoblastic lymphoma, and T/NK large granular lymphocytic leukemia.
- •Measurable disease, defined as at least one bidimensionally measurable site of disease measuring at least 1.5cm in greatest diameter.
- •Failed at least one systemic chemotherapy or biologic therapy for T cell lymphoma unless it can be clearly documented that the patient can not tolerate such therapy.
- •18 years of age or older
- •Life expectancy of greater than 3 months
- •ECOG Performance Status of lesser then or equal to 2
- •Normal organ and marrow function as outlined in the protocol
- •Agree to the use of adequate contraception prior to study entry and for the duration of the study
排除标准
- •Chemotherapy or radiotherapy within 4 weeks prior to entering the study
- •Receiving any other study agents
- •CNS lymphoma requiring active therapy
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to imatinib mesylate
- •Participants requiring concomitant administration of any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible
- •Patient previously received radiotherapy to 25% or greater of the bone marrow
- •Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or lactating women
- •History of a different malignancy except for individuals who have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy
- •HIV-positive individuals on combination antiretroviral therapy
- •Known chronic liver disease
- •Major surgery within 2 weeks prior to study entry
研究组 & 干预措施
Imatinib mesylate
The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
干预措施: Imatinib mesylate (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Disease was evaluated radiologically at baseline, weeks 8, 16, 24 and every 12 weeks thereafter on treatment. Treatment duration was a median of 56 days (range 5-253 days).
Overall response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on International Workshop Criteria (IWC) \[Cheson, et al. JCO 2007\]. Per the International Working Group response criteria in lymphoma (Cheson 2007) for target lesions assessed by CT: Complete response (CR): nodes that were greater than 15 mm in greatest transverse diameter at baseline shrank to less than 15 mm in greatest transverse diameter and those that were 11-15 mm in greatest transverse diameter but had a short axis diameter greater than 10 mm had a short axis diameter less than 10mm and a transverse diameter that remained less than 15 mm; partial response (PR) was defined as a decrease in the sum of the product of the diameter of target lesions by more than 50% but not fulfilling criteria for CR. Overall response was defined as CR+PR. .
次要结局
- Progression-Free Survival(Disease was evaluated radiologically at baseline, on treatment at weeks 8, 16, 24 and every 12 weeks thereafter, off treatment for 6 weeks or until death, whichever occurs first. Treatment duration was a median of 56 days (range 5-253 days).)
- Overall Survival(Participants were followed long-term for survival for the earlier of 6 weeks from the end of treatment or death. Maximum follow-up was 288 days in this study cohort.)
研究者
Eric Jacobsen, MD
Principal Investigator
Dana-Farber Cancer Institute