A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 193
- 主要终点
- Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria
研究概览
简要总结
This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving CCI-779 together with rituximab may kill more cancer cells
详细描述
PRIMARY OBJECTIVES:
I. Determine the overall response rate in patients with relapsed or refractory mantle cell lymphoma treated with CCI-779 and rituximab.
II. Determine the tolerability of this regimen in these patients by assessing toxicity.
SECONDARY OBJECTIVES:
I. Determine the time to disease progression and overall survival of patients treated with this regimen.
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* mantle cell lymphoma (MCL)
- •Relapsed, refractory, or stable disease after prior treatment
- •Tumor must be cyclin D-1 by immunohistochemistry OR 11;14 translocation by fluorescent in situ hybridization or cytogenetics
- •Measurable disease, defined as ≥ 1 of the following:
- •Unidimensionally measurable lymph node or tumor mass ≥ 2 cm by CT scan or MRI
- •Splenic enlargement if spleen is palpable ≥ 3 cm below the left costal margin
- •Malignant lymphocytosis if absolute lymphocytic count ≥ 5,000 AND lymphocytes confirmed to be monoclonal by flow cytometry
- •No known central nervous system involvement (e.g., parenchymal mass or leptomeningeal involvement)
- •Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
- •At least 3 months
- •No other concurrent treatment for MCL
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Direct bilirubin < 1.5 times ULN
- •Aspartate aminotransferase (AST) ≤ 3 times ULN (5 times ULN if liver involvement by MCL is present)
- •Creatinine ≤ 2 times ULN
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •Cholesterol ≤ 350 mg/dL
- •Fasting triglycerides < 400 mg/dL
- •No known HIV positivity
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No other active malignancy requiring treatment OR that would preclude assessment of response to study drugs
- •Prior biologic response modifiers allowed
- •Prior immunotherapy allowed
- •Prior high-dose therapy with stem cell support (i.e., stem cell transplantation) allowed
- •No concurrent prophylactic growth factor to support neutrophils
- •Prior chemotherapy allowed
- •No other concurrent chemotherapy
- •No concurrent corticosteroids to induce an antitumor response
- •Concurrent corticosteroids (≤ 10 mg/day of prednisone or equivalent) for adrenal insufficiency or acute allergic reactions allowed
- •Prior radiotherapy allowed
- •No prior treatment with a mammalian target of rapamycin (mTOR) inhibitor
- •No other concurrent investigational or commercial agents or therapies for MCL
- •No other concurrent immunosuppressive therapy
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
干预措施: rituximab (Biological)
Arm I
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
干预措施: temsirolimus (Drug)
结局指标
主要结局
Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria
时间窗: Up to 12, 28-day cycles.
Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. Partial Response (PR) requires a \>=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses. Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients. We report the Overall Response Rate here.
次要结局
- Time to Progression(Patients were followed up to five years after registration.)
- Duration of Response(Response duration is followed up to 5 years from registration.)
- Toxicity(Assessed during treatment (up to 12, 28-day cycles))
- Overall Survival(Patients were followed for survival status for up to 5 years.)