NCT00031824已完成3 期
Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 104
- 主要终点
- Progression Free Survival
研究概览
简要总结
RATIONALE: Hydroxychloroquine may decrease the immune response and be effective in treating chronic graft-versus-host disease. It is not yet known if standard therapy for graft-versus-host disease is more effective with or without hydroxychloroquine.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard therapy alone with that of standard therapy plus hydroxychloroquine in treating patients who have newly diagnosed chronic graft-versus-host disease.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of prednisone and cyclosporine with vs without hydroxychloroquine in patients with newly diagnosed extensive chronic graft-versus-host disease (GVHD).
Secondary
- Compare the event-free and overall survival in patients treated with these regimens.
- Compare the health-related quality of life, including longitudinal change in and magnitude of persistent disability, in patients treated with these regimens.
- Correlate cytokine levels and T-helper cell subtypes with chronic GVHD activity and response in patients treated with these regimens.
- Correlate whole blood hydroxychloroquine levels with response and toxicity in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 1 Year 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed* newly diagnosed extensive chronic graft-versus-host disease (GVHD) of ≥ 1 organ system (e.g., lip, skin, or liver) documented by all of the following:
- •Clinicopathologic features of GVHD, including involvement of any of the following organ systems:
- •Skin changes
- •Oral changes
- •Hepatic involvement
- •Gastrointestinal involvement
- •Sicca syndrome
- •Pulmonary involvement
- •Myofascial
- •Other inflammatory conditions (e.g., myositis, arthritis, polyserositis, or unexplained pericardial, pleural, or peritoneal effusions)
- •Autoantibodies
- •Extent of disease, defined according to the following classification:
- •Limited chronic GVHD, defined by 1 of the following:
- •Localized skin involvement and/or liver dysfunction
- •Involvement of only 1 target organ
- •Extensive chronic GVHD, defined by 1 of the following:
- •Generalized skin involvement of ≥ 50% of body surface area
- •Localized skin involvement and/or liver dysfunction AND ≥ 1 of the following:
- •Liver histology showing chronic aggressive hepatitis, bridging necrosis, or cirrhosis
- •Eye involvement (Schirmer's test with < 5 mm wetting)
- •Involvement of minor salivary glands or oral mucosa on lip biopsy
- •Involvement of any other target organs
- •Involvement of ≥ 2 target organs
- •Timing of onset, including onset of any of the following types:
- •Progressive onset defined as, evolving directly from acute GVHD, commonly with the development of typical manifestations such as oral or skin lichenoid changes or sclerodermatous skin changes
- •Quiescent onset, defined as developing after the resolution of acute GVHD
- •De novo onset, defined as developing with no prior history of acute GVHD
- •Must have ≥ 1 typical clinical manifestation of chronic GVHD that differs from that of acute GVHD (e.g., rash, anorexia, nausea, emesis, diarrhea, abdominal pain, or cholestasis)
- •Symptoms of acute GVHD allowed at the time of diagnosis of chronic GVHD
- •Prior allogeneic bone marrow, peripheral blood stem cell, or cord blood transplantation from a family member or unrelated donor for malignancy required NOTE: *Histologic confirmation may be "consistent with GVHD"
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Lansky 50-100% OR
- •Karnofsky 50-100%
- •Life expectancy:
- •At least 2 months
- •Hematopoietic:
- •Absolute neutrophil count ≥ 1,000/mm^3, unless due to chronic GVHD (i.e., autoimmune neutropenia or bone marrow suppression)
- •See Disease Characteristics
- •Creatinine < 1.5 times upper limit of normal OR
- •Creatinine clearance ≥ 60 mL/min
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No lysosomal storage disorder
- •No uncontrolled infection (e.g., persistent bacterial, fungal, or viral infection despite appropriate antimicrobial therapy)
- •No G6PD deficiency
- •No history of psoriasis or porphyria
- •No hypersensitivity to 4-aminoquinolines
- 另有 31 项未显示
排除标准
- 未提供
结局指标
主要结局
Progression Free Survival
时间窗: Length of study
次要结局
- Compare the efficacy of a two-drug regimen(Length of study)
- Compare conventional outcomes measures(Length of study)
- To determine if cytokine levels and T helper cell subtypes (Th1 and Th2) correlate with chronic GVHD activity and response(Length of study)
- Determine if whole blood hydroxychloroquine levels correlate with response and toxicity.
研究者
研究点 (104)
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