A Phase 2 Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Overall Response Rate
研究概览
简要总结
This research study is studying Daratumumab as a possible treatment for Waldenström Macroglobulinemia.
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved Daratumumab for this specific disease but it has been approved for other uses.
Daratumumab is a monoclonal human antibody. An antibody recognizes a specific protein and binds to it. Daratumumab binds to a protein called CD38 located on the surface of B cells like WM. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories.
In this research study, the investigators are evaluating the efficacy of Daratumumab as a single agent in participants with WM that has come back or has shown no response to previous treatment.
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 Waldenström Macroglobulinemia (Owen et al. 2003), and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia (Kyle et al. 2003)
- •At least one previous treatment for WM with either documented disease progression or no response (stable disease) to the most recent treatment regimen
- •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
- •Participants with symptomatic hyperviscosity or serum IgM >5,000 mg/dL to undergo plasmapheresis prior to treatment initiation
- •Age ≥18 years
- •ECOG performance status ≤2 (see Appendix A)
- •Participants must have preserved organ and marrow function as defined below:
- •Absolute neutrophil count ≥ 1,000/mcL
- •Platelets ≥ 50,000/mcL
- •Hemoglobin ≥ 8 g/dL
- •Total bilirubin ≤ 1.5 mg/dL or < 2 mg/dL if attributable to hepatic infiltration by neoplastic disease
- •AST/ALT ≤ 2.5 × institutional upper limit of normal
- •EGFR ≥ 30 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 90 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. FCBP must have a negative serum pregnancy test at screening.
- •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 study participation.
- •Concurrent use of any other anti-cancer agents or treatments or any other investigational agents.
- •Any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •Known CNS lymphoma.
- •New York Heart Association classification III or IV heart failure.
- •Known history of Human Immunodeficiency Virus (HIV), active infection with Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV).
- •Lactating or pregnant women.
- •Grade >2 toxicity (other than alopecia) continuing from prior anti-cancer therapy.
- •History of non-compliance to medical regimens.
研究组 & 干预措施
Daratumumab
- Daratumumab will be administered in three phases: Induction, consolidation and maintenance
- During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day
- During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle
- During maintenance, daratumumab will be administered on day 1 of each 28-day cycle
干预措施: Daratumumab (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 Complete Response(2 years)
- Progression Free Survival(4 years)
- Number of Participants With Partial Response(2 years)
- Number of Participants With Minor Response(2 years)
- Number of Participants With Very Good Partial Response(2 years)
研究者
Jorge J. Castillo, MD
MD
Dana-Farber Cancer Institute