NCT06240754招募中2 期
A Pilot Study of Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2: A Decentralized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Best hematologic response
研究概览
简要总结
Study researchers think that a drug called enasidenib may help people with clonal cytopenia of undetermined significance (CCUS) because the drug blocks the mutated IDH2 protein, which may improve blood cell counts. The purpose of this study is to find out whether enasidenib is a safe and effective treatment for CCUS.
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
- •Unexplained cytopenia for at least 6 months. Cytopenia is defined as the presence of ≥1 blood count indexes below the following thresholds:
- •Hgb <10 g/dL
- •ANC <1.8 × 109/L
- •Platelets <100 × 109/L
- •IDH2 gene mutation (R140 or R172), performed locally, at a frequency ≥ 2%.
- •At least 18 years of age.
- •ECOG performance status 0-2
- •Adequate organ function as defined below:
- •AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- •Serum total bilirubin < 1.5 x IULN (un upper limit of bilirubin 5 mg/dL is acceptable if it can be attributed to Gilbert's syndrome or erythropoiesis)
- •Creatinine clearance > 50 mL/min by Cockcroft-Gault glomerular filtration rate estimation or serum creatinine ≤ 2 x IULN
- •The effects of enasidenib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 24 months after the last dose of enasidenib. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and for 4 months after the last dose of enasidenib.
- •Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
排除标准
- •Indication of hematologic disease by bone marrow biopsy within 6 months of study entry.
- •Evidence of disease progression from time of bone marrow biopsy to enrollment based on investigator review of symptoms and complete blood counts
- •Active malignancy (defined as > 1 cm disease on most recent CT scan in the past 6 months).
- •Currently receiving therapy for solid tumor malignancy or received within the last 6 months.
- •Currently receiving any other investigational agents.
- •Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
- •A history of allergic reactions attributed to compounds of similar chemical or biologic composition to enasidenib or other agents used in the study.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- •Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 72 hours of study entry.
- •Positive direct Coombs test.
研究组 & 干预措施
Enasidenib
Experimental
Participants will receive enasidenib 100 mg daily for 18 cycles (each cycle is 28 days).
Participants will continue treatment with enasidenib until confirmed progression to AML or MDS, development of unacceptable toxicity, or suspicion of disease progression, provided the patient is deriving clinical benefit, which will be determined at the discretion of the principal investigator.
干预措施: Enasidenib (Drug)
结局指标
主要结局
Best hematologic response
时间窗: Up to 18 cycles (each cycle is 28 days) of treatment (up to approximately 17 months)
Hematologic response to enasidenib will be evaluated according to a modified version of the IWG 2006 Criteria for Hematologic Improvement for patients with MDS on clinical trials
次要结局
- Toxicity as measured by the number of adverse events experienced by participant(From start of treatment through 30 days after the last day of treatment (up to approximately 18 months))
- Duration of hematologic improvement(From start of treatment through completion of treatment (estimated to be 17 months))
- Change in mutant IDH2 variant allele fraction(Baseline, day 1 of cycles 3/6/9/12/15 (each cycle is 28 days), and end of treatment (up to approximately 17 months))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of Enasidenib in People With Clonal Cytopenia of Undetermined SignificanceClonal Cytopenia of Undetermined SignificanceCCUS Clonal Cytopenia of Undetermined SignificanceNCT05102370Memorial Sloan Kettering Cancer Center4
已完成
1 期
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)Hepatic ImpairmentHepatic InsufficiencyNCT06575959Merck Sharp & Dohme LLC20
已完成
1 期
A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)HealthyNCT06597760Merck Sharp & Dohme LLC24
进行中（未招募）
2 期
A Study of Enasidenib in People With T-Cell LymphomaT-cell LymphomaNCT06756308Memorial Sloan Kettering Cancer Center2
已完成
1 期
A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)HealthyRenal ImpairmentNCT06643377Merck Sharp & Dohme LLC27