Phase II Study of Pegylated Ifná-2a (Pegasys) in Patients With Chronic Myeloid Leukemia Who Have Minimal Residual Disease While Receiving Therapy With Tyrosine Kinase Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)
研究概览
简要总结
The goal of this clinical research study is to learn if adding pegylated interferon-alfa 2a (Pegasys) to the TKI that you are already receiving can help to control CML. The safety of this treatment combination will also be studied.
Pegasys is a form of the drug interferon. It is designed to help the body's immune system to fight infections. It may also affect the body's response to cancer.
A TKI (imatinib mesylate, nilotinib, or dasatinib) is designed to bind to and shut off a protein in tumor cells called Bcr-Abl. Shutting Bcr-Abl off may prevent CML cells from growing, and may cause them to die.
You are already receiving a TKI. This consent form will describe the administration of Pegasys, any tests and procedures that need to be performed while you are receiving Pegasys, and any risks/benefits there may be from receiving Pegasys.
详细描述
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive Pegasys through a needle under the skin 1 time each week while you are on study. You will be taught how to use the study drug at the first visit and will administer it to yourself at all future doses.
You will continue receiving the TKI you are already taking at the dose and frequency you have been receiving it when you began taking part in this study.
Study Visits:
At every study visit, you will be asked about any side effects you may have had and to list any drugs you may be taking.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 16 years or older with Philadelphia chromosome (Ph)-positive or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR).
- •Patients are receiving an FDA-approved TKI for the management of CML.
- •Patients must have received TKI therapy for at least 24 months and not have increased their TKI dose in the last 6 months.
- •Patients must be in complete cytogenetic remission.
- •Patients must have detectable BCR-ABL1 transcript levels meeting at least one of the following criteria:
- •The patient has received therapy for at least 2 years and does not have a sustained major molecular response, or
- •The patient has received therapy for at least 5 years and does not have a sustained complete molecular response.
- •Patients must not have had a known continuous interruption of TKI therapy of greater than 14 consecutive days or for a total of 6 weeks in the 6 months prior to enrollment.
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
- •Eastern Cooperative Oncology Group (ECOG) performance status </=
- •Adequate organ function defined as: bilirubin < 2x upper limit of normal (ULN) (unless associated with Gilbert's syndrome), creatinine </= 1.5x ULN, and serum glutamate pyruvate transaminase (sGPT) or serum glutamate oxaloacetate transaminase (sGOT) </= 2.5x ULN.
- •Men and women of childbearing potential should practice effective methods of contraception. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week of enrollment.
排除标准
- •Patients receiving any non-FDA approved TKI.
- •Patients who are pregnant or breast-feeding.
- •Patients with clinically significant heart disease (NYHA Class III or IV).
研究组 & 干预措施
PEG-IFNá-2a
PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
干预措施: PEG-IFNá-2a (Drug)
结局指标
主要结局
Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)
时间窗: 12 months from start of treatment with PEG-IFNá-2a
Molecular response defined as: major molecular response (MMR) corresponds to a BCR-ABL1/ABL1 ratio of \<=0.01. Complete molecular response (CMR) is defined as undetectable BCR-ABL1 transcripts. Molecular response measured every 3 months (a total of 4 assessments within one year of therapy).
次要结局
未报告次要终点