NCT00786812已完成4 期
An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months
研究概览
简要总结
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the [CAMN107A2109] study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •patients currrently participating in Novartis study CAMN107A2109
- •imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC)
- •males or females ≥18 years of age
- •WHO Performance Status of ≤ 2
- •patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor
排除标准
- •Impaired cardiac function; use of therapeutic coumarin derivatives
- •patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days
- •patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
- •patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy
- •,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy
研究组 & 干预措施
CAMN107A2109 Extension Patients
Other
干预措施: Nilotinib (Drug)
AMN107 Naive
Other
干预措施: Nilotinib (Drug)
结局指标
主要结局
Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months
时间窗: 3 - 24 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Long Term Effects On Recipients of Hematopoietic Stem Cell TransplantationBlood and Marrow Transplant (BMT)NCT01629017Stanford University800
撤回
1 期
A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant RecipientsHematologic DiseasesStem Cell TransplantsNCT03097796Pulmotect, Inc.
招募中
2 期
Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With TafasitamabHematologic MalignanciesNCT06465433Incyte Corporation25
已完成
不适用
Hematopoietic Stem Cell Transplantation for Treatment of Multiple Sclerosis in SwedenMultiple Sclerosis, Relapsing-RemittingMultiple SclerosisNCT05029206Uppsala University174
已完成
3 期
A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular LymphomaLymphoma, FollicularNCT02569996Hoffmann-La Roche124