NCT06660355招募中2 期
Phase II Randomized Study of Ruxolitinib vs Prednisone as First-Line Therapy for Chronic Graft vs Host Disease Needing Systemic Therapy
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
- 120
- 试验地点
- 9
- 主要终点
- Treatment Success
研究概览
简要总结
Allogeneic transplant is potentially curative for hematological malignancies but its use is limited by the development of GVHD. Ruxolitinib now has FDA approval for treatment of chronic GVHD that has failed 1-2 prior lines of therapy based on a prior large, randomized phase III study. Given this evidence of safety and efficacy in the early refractory setting (after prednisone failure), Ruxolitinib represents an ideal agent to test in the primary therapy setting. Here investigators propose a phase 2 randomized study to compare Ruxolitinib to prednisone as a first-line therapy in the treatment of chronic GVHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years.
- •Karnofsky performance status ≥60%.
- •Patients with a diagnosis of chronic GVHD per NIH diagnostic criteria5 who are in need for first systemic therapy as per treating physician's discretion, Overlap chronic GVHD will be allowed.
- •No new immune suppressive therapy added within preceding 2 weeks prior to study enrolment.
- •Able to take oral medications.
- •Participants must have adequate organ and marrow function as defined below:
- •absolute neutrophil count ≥1,000/mcL
- •platelets ≥30,000/mcL
- •Hemoglobin ≥ 7 g/dL
- •Bilirubin ≤ 3 times institutional upper limit of normal (ULN) unless attributable to GVH
- •d. AST(SGOT)/ALT(SGPT) ≤5 × institutional ULN unless attributable to GVH e. creatinine clearance ≥30 ml/min
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should 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 study participation, and 4 months after completion of study drug administration.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Previously treated with systemic immune suppressive therapy for chronic GVHD (where the indication for start of that systemic immune suppressive therapy was chronic GVHD).
- •Patients with clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within 6 months, New York Heart Association class III or IV heart failure will be excluded.
- •Relapse malignancy post- transplant. Molecular relapse or Mixed chimerism or treated relapse in remission may be allowed on case by case basis but needs discussion with the study Chair/PI
- •Active hepatitis B, hepatitis C and HIV will be excluded.
- •Any uncontrolled infection at the time if enrollment will be excluded.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ruxolitinib.
- •Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women and lactating women are excluded from this study because of the potential for teratogenic or abortifacient effects and an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Ruxolitinib, breastfeeding should be discontinued if the mother is treated with Ruxolitinib.
- •Current or history of active Tuberculosis.
研究组 & 干预措施
Ruxolitinib Treatment Arm
Experimental
Ruxolitinib is administered as 10 mg orally twice daily in 28-day cycles.
干预措施: Ruxolitinib (Drug)
Prednisone Treatment Arm
Active Comparator
Prednisone will be started at 1mg/kg/day based on patient current body weight in kilograms.
干预措施: Prednisone (Drug)
结局指标
主要结局
Treatment Success
时间窗: 6 months
Treatment Success is defined as C7D1 NIH CR/PR without death or new line of immune suppressive therapy and will be estimated for both arms.
次要结局
- Treatment Success Rate(6 months)
研究者
研究点 (9)
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