NCT02677324已完成2 期
Phase II Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia
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
- 33
- 试验地点
- 4
- 主要终点
- Overall Response Rate
研究概览
简要总结
This research study is studying a targeted therapy as a possible treatment for relapsed or refractory Waldenstrom's Macroglobulinemia (WM). This study is using the study intervention ABT-199.
详细描述
This research study is a Phase II clinical trial. ABT-199 is a pill that blocks BCL-2, a protein that is important for the survival of WM cells.
The purpose of this research study is to evaluate how well the study drug works and the safety of ABT-199 as a single agent in participants with WM that has come back or has shown no response to previous treatment.
The FDA (the U.S. Food and Drug Administration) has not approved ABT-199 as a treatment for any disease.
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
- •Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia (Owen 2003; Kyle 2003).
- •Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of > 2 times the upper limit of normal of each institution is required.
- •Have received at least one prior therapy for WM.
- •Age ≥ 18 years.
- •ECOG performance status <2 (see Appendix A).
- •Participants must have normal organ and marrow function (growth factors cannot be given prophylactically to establish eligibility) as defined below:
- •Absolute neutrophil count > 1,000/mm3
- •Platelets > 50,000/mm3
- •Hemoglobin > 8 g/dL
- •Total bilirubin ≤ 1.5 mg/dL or < 2 mg/dL if attributable to hepatic infiltration by neoplastic disease
- •AST (SGOT) and ALT (SGPT) < 2.5X the institutional upper limit of normal
- •Creatinine clearance ≥50 ml/min
- •Not on any active therapy for other malignancies with the exception of topical therapies for basal cell or squamous cell cancers of the skin.
- •Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or have or will have complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) while participating in the study; and 2) for at least 28 days after discontinuation from the study. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. FCBP must be referred to a qualified provider of contraceptive methods if needed.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form.
- •Concurrent use of any other anti-cancer agents or treatments or any other study agents.
- •Prior exposure to ABT-199 or BCL2 inhibitors.
- •Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the patient, including symptomatic hyperviscosity; alter the absorption, distribution, metabolism or excretion of ABT-199; or impair the assessment of study results.
- •Grade > 2 toxicity (other than alopecia) continuing from prior anti-cancer therapy.
- •Known CNS lymphoma.
- •Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
- •New York Heart Association classification III or IV heart failure.
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- •Known history of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV) infection.
- •Lactating or pregnant women.
- •Inability to swallow tablets.
- •History of non-compliance to medical regimens.
- •Unwilling or unable to comply with the protocol.
研究组 & 干预措施
ABT199
Experimental
ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles
干预措施: ABT199 (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 2 years
Overall Response Rate= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).
次要结局
- Number of Participants With Very Good Partial Response(2 years)
- Number of Participants With Complete Response(2 years)
- Number of Participants With Minor Response(2 years)
- Overall Response Rate Among Participants Without CXCR4 Mutations(2 years)
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0(2 years)
- Number of Participants With Partial Response(2 years)
- Number of Participants With Stable Disease(2 years)
- Progression Free Survival(4 years)
- Overall Response Rate Among CXCR4 Mutated Participants(2 years)
研究者
Jorge J. Castillo, MD
Jorge J. Castillo, MD
Dana-Farber Cancer Institute
研究点 (4)
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