A Phase II Study of Oral Clofarabine in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- All Phase I-II Participants: Overall Response Rate (ORR)
研究概览
简要总结
Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and works in two different ways. It affects the development of new cancer cells by blocking two enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing cancer cells to die by disturbing components within the cancer cell. This causes the release of a substance that is fatal to the cell.
This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin lymphomas.
详细描述
- Each treatment cycle lasts four weeks during which time the participant will be taking study drug for the first three weeks only. Participants will be supplied with a study medication-dosing calendar for each treatment cycle.
- Clofarabine is a tablet that will be taken orally in the morning once daily on days 1 through 21 of each 28-day cycle. Participants can receive up to a total of 6 cycles if they do not experience any unacceptable side effects and if their cancer does not get worse.
- The following tests and procedures will be performed at specified intervals through out the treatment period: blood tests, physical examinations, vital signs, radiological exams and urine tests.
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 relapsed or refractory NHL that includes: follicular lymphoma of any grade; marginal zone lymphoma; small lymphocytic lymphoma/chronic lymphocytic leukemia; mantle cell lymphoma; lymphoplasmacytic lymphoma; low-grade B-cell lymphoma not otherwise specified; diffuse large B-cell lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma.
- •One or more prior line of chemotherapy, immunotherapy, or radioimmunotherapy.
- •Measurable disease on cross sectional imaging of at least 2cm.
- •ECOG Performance Status 0-2
- •18 years of age or older
- •Life expectancy of greater than 3 months
- •Normal organ and marrow function as outlined in the protocol
- •Must agree to use adequate contraception prior to study entry and for the duration of study participation
排除标准
- •Patients who have had chemotherapy, rituximab, or radiotherapy within 4 weeks, or radioimmunotherapy within 8 weeks prior to entering the study
- •Receiving any other investigational agent
- •Known brain metastases
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Clofarabine
- •Systemic fungal, bacterial, viral, or other infection not controlled
- •Pregnant or lactating
- •Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for over one year
- •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
- •Prior allogeneic stem cell transplantation
研究组 & 干预措施
Clofarabine
Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
干预措施: Clofarabine (Drug)
结局指标
主要结局
All Phase I-II Participants: Overall Response Rate (ORR)
时间窗: after at most 6 28-day cycles
Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Phase I Participants Only: Overall Response Rate (ORR)
时间窗: after at most 6 28-day cycles
Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)(after at most 6 28-day cycles)
- All Phase I-II Participants: Progression-free Survival (PFS)(at 1 and 2 years)
- All Phase I-II Participants: Overall Survival (OS)(3 years)
- Phase I Participants: Progression-free Survival (PFS)(at 17 months)
- Phase I Participants: Safety(during 6 28-day cycles and 90 days out)
- All Phase I-II Participants: Safety(during 6 28-day cycles and 90 days out)
- All Phase I Participants: Overall Survival (OS)(at 17 months)
- Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)(after at most 6 28-day cycles)
研究者
Jeremy Abramson, MD
Director, Lymphoma Program
Massachusetts General Hospital