NCT01891968已完成2 期
Phase II Study of Subcutaneous Bortezomib for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Overall Response (OR)
研究概览
简要总结
The goal of this clinical research study is to learn if bortezomib can help to control MDS. The safety of this drug will also be studied.
Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer cells to die.
详细描述
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive bortezomib as an injection under the skin on Days 1, 4, 8, and 11 of each 21-day cycle.
Study Visits:
At each visit, you will be asked about any drugs you may be taking and any side effects you may be having.
One (1) time a week during Cycle 1, blood (about 2 tablespoons) will be drawn for routine 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
- •Voluntary signed informed consent before performance of any study-related procedure not part of normal medical care, indicating that that the patient is aware of the investigational nature of the study in keeping with the policies of MD Anderson Cancer Center (MDACC) and with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- •Presence of phosphorylated p65 NF-kB component in at least 5% of bone marrow cells
- •Age >/= 18 years of age at time of signing consent
- •Confirmed MDS by bone marrow biopsy according to World Health Organization (WHO) or French-American-British (FAB) criteria.
- •Classification by the International Prognostic Score System (IPSS) as low or intermediate-1 risk MDS according to cytogenetics, blood cytopenias and % bone marrow blasts within 28 days of the first dose of treatment in this study.
- •Patients must have received at least one prior therapy for MDS. Patients could have received transplant for MDS
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or
- •Adequate liver function: Total bilirubin </= 1.5 × the upper limit of normal (ULN), unless presence of Gilbert's Syndrome. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </= 2.5 × ULN or </= 5.0 ULN if hepatic involvement is present as determined by the investigator
- •Adequate renal function: Serum creatinine </= 2 mg/dL or a calculated creatinine clearance of >/= 50 mL/min (using the Cockcroft and Gault method).
- •Male patients, even if surgically sterilized (ie, status postvasectomy), who agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study treatment, or agree to completely abstain from heterosexual intercourse.
- •Female patients who are postmenopausal for at least 1 year before the Screening visit, or are surgically sterile, or if they are of childbearing potential, must have a negative pregnancy test within 72 hours of treatment start date and agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study treatment, OR agree to completely abstain from heterosexual intercourse
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
排除标准
- •Significant medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study.
- •Any severe concurrent disease or condition (including active, uncontrolled systemic infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia) that, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- •Pregnant or lactating females.
- •Patient has >/= Grade 2 peripheral neuropathy
- •Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
- •Patient has hypersensitivity to bortezomib, boron, or mannitol
- •Current diagnosis of another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- •Treatment with other investigational agents, chemotherapy, or immunotherapy within 14 days of the start of this trial and throughout the duration of this trial.
- •Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
研究组 & 干预措施
Bortezomib
Experimental
Bortezomib administered via subcutaneous route at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21 day cycle. A course of treatment will be 21 days.
干预措施: Bortezomib (Drug)
结局指标
主要结局
Overall Response (OR)
时间窗: 8 weeks
Primary outcome is overall response (OR) including hematologic improvement defined by International Working Group (IWG), complete remission, partial remission and marrow complete remission.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in RemissionAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromeAdult Acute Minimally Differentiated Myeloid Leukemia (M0)Adult Acute Myeloblastic Leukemia Without Maturation (M1)Adult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Promyelocytic Leukemia (M3)Adult Erythroleukemia (M6a)Adult Pure Erythroid Leukemia (M6b)Secondary Acute Myeloid LeukemiaNCT01465386Fred Hutchinson Cancer Center6
已完成
2 期
A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple MyelomaMultiple MyelomaNCT00872521Janssen-Cilag Pty Ltd107
进行中（未招募）
2 期
Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN DeletionMetastatic Castration-resistant Prostate CancerNCT06029998University of Utah22
已完成
不适用
Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL AmyloidosisLight Chain Deposition Disease (LCDD or MIDD)Light Chain and Heavy Chain Deposition Disease (LHCDD or MIDD)Monoclonal Immunoglobulin Deposition Disease (MIDD)AmyloidosisNCT01383759Memorial Sloan Kettering Cancer Center20
已完成
1 期
Bortezomib in Patients With Chronic Graft Versus Host DiseaseGraft Versus Host DiseaseNCT01672229Mehrdad Abedi, MD16