NCT00074074已完成2 期
Randomized Phase II Trial With Infliximab (Remicade) in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia
European Organisation for Research and Treatment of Cancer - EORTC19 个研究点 分布在 6 个国家目标入组 46 人开始时间: 2003年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 19
- 主要终点
- Best response as measured by Cheson response criteria
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as infliximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to study the effectiveness of infliximab in treating patients who have myelodysplastic syndrome.
详细描述
OBJECTIVES:
- Determine the therapeutic activity of 2 different doses of infliximab on peripheral blood cell count and peripheral and bone marrow blast cell count in patients with low- or intermediate-risk myelodysplastic syndromes.
- Determine the subjective and objective toxicity of these regimens in these patients.
- Determine the response rates (complete and partial response and hematological improvement) in patients treated with these regimens.
- Determine the duration of response in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to cytogenetics (good vs intermediate vs unknown due to failure), overall International Prognostic Scoring System score (low [0] vs intermediate 1 [0.5-1.0] vs intermediate 2 [1.5-2.0]), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive infliximab IV on days 1, 15, 43, 71, 99, 127, 155, and 183 in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive a higher dose of infliximab as in arm I. Patients achieving response (complete or partial response or hematological improvement) continue therapy beyond day 183 in the absence of disease progression.
Patients are followed at 2 weeks and then every 3 months thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Confirmed diagnosis (within the past month) of low- or intermediate-risk myelodysplastic syndromes (MDS) meeting all of the following criteria:
- •No more than 10% bone marrow blasts (corresponding to refractory anemia [RA], RA with ringed sideroblasts, or RA with excess blasts)
- •Meets at least 1 of the following hematopoietic criteria:
- •Hemoglobin no greater than 10 g/dL OR red blood cell transfusion dependent
- •Neutrophil count no greater than 1,500/mm^3
- •Platelet count no greater than 100,000/mm^3 OR platelet transfusion dependent
- •No poor cytogenetics (complex abnormalities or involvement of chromosome 7)
- •Patients with unknown cytogenetics may be eligible provided reasonable efforts have been made for determining the cytogenetic profile and the results are considered a failure (e.g., normal karyotype [NN] with no more than 10 metaphases)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •See Disease Characteristics
- •No history of documented hepatitis C
- •No documented active hepatitis B
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT less than 2.5 times ULN
- •Creatinine less than 1.5 times ULN
- •Cardiovascular
- •No New York Heart Association class III or IV heart disease
- •No clinical history or evidence of congestive heart failure
- •No severe cardiac dysfunction
- •LVEF greater than 35%
- •No prior or concurrent active or latent tuberculosis (TB)
- •No evidence of prior or concurrent active TB (i.e., fibrotic or pleural scarring, pulmonary nodules, mediastinal and/or hilar lymphadenopathy, upper lobe volume loss, or cavitation) by chest x-ray
- •Negative intradermal tuberculin skin test (i.e., induration less than 5 mm)
- •No severe pulmonary dysfunction
- •Immunologic
- •No prior or concurrent opportunistic infection (e.g., herpes zoster, cytomegalovirus, Pneumocystic carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within the past 6 months
- •No concurrent severe (CTC grade III or IV) active, chronic, or recurrent infections
- •No recent history of allergies
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study participation
- •No prior clinically significant adverse event to murine or chimeric proteins or human/murine recombinant products
- •No recent contact with an individual with active TB
- •No poor medical risk due to other systemic disease
- •No multiple sclerosis or other demyelinating disorder
- •No peripheral neuropathy greater than CTC grade 1
- •No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior infliximab or other monoclonal antibodies
- •At least 6 weeks since prior hematopoietic growth factors for MDS
- •At least 3 months since prior therapy targeted at reducing tumor necrosis factor (TNF) alpha (e.g., pentoxifylline, thalidomide, or etanercept)
- 另有 17 项未显示
排除标准
- 未提供
结局指标
主要结局
Best response as measured by Cheson response criteria
次要结局
- Duration of highest grade toxicity as assessed by CTCAE v3.0 after response
研究者
研究点 (19)
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